Healthy
Conditions
Keywords
probiotics, microbiota, survival, gastrointestinal, wellness
Brief summary
The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.
Detailed description
A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.
Interventions
DIETARY_SUPPLEMENTB. subtilis R0179
B. subtilis R0179 for a period of 4 weeks. One capsule per day.
DIETARY_SUPPLEMENTPlacebo
Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
Sponsors
Lallemand Human Nutrition
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Participants * Are 18-50 years of age * Are willing and able to complete the Informed Consent Form in English * Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment * Are currently moderately active as determined by the GPAQ (Global Physical Activity Questionnaire) * Are willing to have height and weight measured and to provide demographic information (age, race, sex) * Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day) * Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study * Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout * Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided * Are willing to have internet access for the duration of the study
Exclusion criteria
Potential Participants will be excluded if they * Do not meet the inclusion criteria * Are currently taking medications for constipation or diarrhea * Have taken antibiotics within the past four weeks prior to randomization * Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study * Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | Weeks 1, 5, and 6 | Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Weekly for 6 weeks | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | 6 weeks | Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g). |
Countries
United States
Participant flow
Recruitment details
Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.
Pre-assignment details
A one week baseline period was to be completed before participants were randomized to intervention arms. Participants that failed to complete study requirements during this period were withdrawn due to noncompliance.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day. | 20 |
| B. Subtilis R0179 (0.1 Billion CFU) B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 21 |
| B. Subtilis R0179 (1 Billion CFU) B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 20 |
| B. Subtilis R0179 (10 Billion CFU) B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day. | 20 |
| Total | 81 |
Baseline characteristics
| Characteristic | Placebo | B. Subtilis R0179 (0.1 Billion CFU) | B. Subtilis R0179 (1 Billion CFU) | B. Subtilis R0179 (10 Billion CFU) | Total |
|---|---|---|---|---|---|
| Activity Level | 185.5 mins of moderate and intense activity STANDARD_DEVIATION 70.9 | 197.3 mins of moderate and intense activity STANDARD_DEVIATION 84.5 | 168.3 mins of moderate and intense activity STANDARD_DEVIATION 74.9 | 199.0 mins of moderate and intense activity STANDARD_DEVIATION 57.9 | 185.9 mins of moderate and intense activity STANDARD_DEVIATION 72.4 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 21 Participants | 20 Participants | 20 Participants | 81 Participants |
| Age, Continuous | 23 years | 23 years | 22 years | 23 years | 23 years |
| BMI Percentiles 85th-94th % (Overweight) | 6 participants | 7 participants | 4 participants | 9 participants | 26 participants |
| BMI Percentiles <85th % (Healthy Weight) | 10 participants | 12 participants | 13 participants | 9 participants | 44 participants |
| BMI Percentiles >= 95th % (Obese) | 4 participants | 2 participants | 3 participants | 2 participants | 11 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 7 participants | 2 participants | 2 participants | 13 participants |
| Race/Ethnicity, Customized Black | 4 participants | 2 participants | 2 participants | 2 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 2 participants | 3 participants | 2 participants | 10 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 9 participants | 9 participants | 13 participants | 14 participants | 45 participants |
| Region of Enrollment United States | 20 participants | 21 participants | 20 participants | 20 participants | 81 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 8 Participants | 10 Participants | 42 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 12 Participants | 10 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 1 / 21 | 0 / 22 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 21 | 0 / 22 | 0 / 20 |
Outcome results
Primary
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).
Time frame: Weeks 1, 5, and 6
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 1 | 1.6 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 6 | 1.5 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 6 | 1.9 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 6 | 1.7 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 1 | 1.5 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 5 | 1.6 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 1 | 1.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 5 | 1.8 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 5 | 1.7 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 5 | 1.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 6 | 1.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 1 | 1.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 1 | 1.8 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 6 | 1.8 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 5 | 1.9 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 5 | 1.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 6 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 5 | 1.3 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 6 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 5 | 1.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 5 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 1 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 1 | 1.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 6 | 1.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 1 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 6 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 5 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 6 | 1.3 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 1 | 1.3 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 1 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 5 | 1.9 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 1 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 5 | 1.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 6 | 1.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 1 | 1.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 5 | 1.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 6 | 1.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 1 | 1.5 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 6 | 1.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 1 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 5 | 1.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 6 | 1.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 1 | 1.3 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 5 | 1.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 6 | 1.4 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 1 | 1.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 5 | 1.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 6 | 1.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 6 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 5 | 1.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 1 | 1.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 1 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Reflux) Week 1 | 1.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Abdominal Pain) Week 6 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 6 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 1 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 6 | 1.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Diarrhea) Week 5 | 1.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Constipation) Week 5 | 1.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | GSRS (Indigestion) Week 5 | 1.6 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 1 | 0.5 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 2 | 0.4 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 3 | 0.4 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 4 | 0.4 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 5 | 0.6 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 6 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 6 | 0.3 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 2 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 4 | 0.2 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 5 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 6 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 2 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 4 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 1 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaire (Behavioral) Week 3 | 0.5 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 1 | 1.55 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 6 | 1.5 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Weeks 2-5 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 1 | 1.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 6 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Weeks 2-5 | 1.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Weeks 2-5 | 1.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 1 | 1.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 6 | 1.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 1 | 1.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Week 6 | 1.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaire (Bowel Mov.) Weeks 2-5 | 1.5 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 4 | 0.4 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 6 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 4 | 0.1 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 3 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 4 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 1 | 0.2 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 4 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaire (Cephalic) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 4 | 0.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 6 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 6 | 0.1 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 1 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 3 | 0.2 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 2 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 4 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 6 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 5 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 1 | 0.4 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 5 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 6 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 2 | 0.7 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 4 | 0.7 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 1 | 0.4 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaire (Constipation) Week 3 | 0.6 units on a scale | Standard Error 0.2 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 4 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 5 | 0.4 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 6 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 6 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 1 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 2 | 0.2 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 2 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 4 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 5 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 2 | 0.1 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 4 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaire (Diarrhea) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 1 | 0.2 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 2 | 0.3 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 4 | 0.4 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 5 | 0.3 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 4 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 1 | 0.1 units on a scale | Standard Error 0.4 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 2 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 2 | 0.1 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 4 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 6 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 1 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 5 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 6 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 4 | 0.2 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 1 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaire (ENT) Week 3 | 0.2 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 1 | 0.05 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 2 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 3 | 0.1 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 6 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 6 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 4 | 0.02 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 1 | 0.003 units on a scale | Standard Error 0.003 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 5 | 0.1 units on a scale | Standard Error 0.03 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 6 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 5 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 1 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 5 | 0.03 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 6 | 0.08 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 2 | 0.03 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 4 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 1 | 0.1 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaire (Emetic) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 1 | 0.1 units on a scale | Standard Error 0.02 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 2 | 0.1 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 3 | 0.04 units on a scale | Standard Error 0.03 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 4 | 0.1 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 5 | 0.1 units on a scale | Standard Error 0.04 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 6 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 6 | 0.02 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 4 | 0.02 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 1 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 3 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 2 | 0.02 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 5 | 0.02 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 2 | 0.04 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 3 | 0.1 units on a scale | Standard Error 0.04 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 4 | 0.1 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 6 | 0.01 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 5 | 0.02 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 1 | 0.01 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 5 | 0.02 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 6 | 0.02 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 2 | 0.04 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 4 | 0.04 units on a scale | Standard Error 0.02 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 1 | 0.03 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaire (Epidermal) Week 3 | 0.05 units on a scale | Standard Error 0.03 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 1 | 1.1 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 2 | 0.9 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 3 | 0.9 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 4 | 1.0 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 5 | 0.8 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 6 | 0.6 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 6 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 4 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 1 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 3 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 2 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 5 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 2 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 3 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 4 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 6 | 0.5 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 5 | 0.6 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 1 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 5 | 0.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 6 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 2 | 0.9 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 4 | 0.9 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 1 | 0.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaire (Fatigue) Week 3 | 0.9 units on a scale | Standard Error 0.2 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 1 | 0.5 units on a scale | Standard Error 0.8 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 2 | 0.5 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 3 | 0.6 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 4 | 0.6 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 5 | 0.6 units on a scale | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 6 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 6 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 4 | 0.3 units on a scale | Standard Error 0.01 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 1 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 2 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 5 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 2 | 0.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 3 | 0.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 4 | 0.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 6 | 0.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 5 | 0.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 1 | 0.6 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 5 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 6 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 2 | 0.5 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 4 | 0.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 1 | 0.7 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaire (GI Distress) Week 3 | 0.6 units on a scale | Standard Error 0.1 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 1 | 6.8 Hours | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 2 | 6.7 Hours | Standard Error 0.1 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 3 | 6.5 Hours | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 4 | 6.6 Hours | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 5 | 6.8 Hours | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 6 | 6.8 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 6 | 7.0 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 4 | 7.0 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 1 | 6.6 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 3 | 6.8 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 2 | 6.8 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 5 | 7.0 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 2 | 7.1 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 3 | 7.1 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 4 | 7.3 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 6 | 7.1 Hours | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 5 | 6.9 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 1 | 7.1 Hours | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 5 | 6.9 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 6 | 6.7 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 2 | 6.9 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 4 | 6.8 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 1 | 6.6 Hours | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaire (Hours of Sleep) Week 3 | 6.7 Hours | Standard Error 0.2 |
Primary
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Time frame: Weekly for 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 1 | 0.8 units on a scale | Standard Error 0.2 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 4 | 0.9 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 3 | 0.9 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 6 | 0.8 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 5 | 0.9 units on a scale | Standard Error 0.3 |
| Placebo | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 2 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 3 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 1 | 0.7 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 2 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 4 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 5 | 0.4 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 6 | 0.3 units on a scale | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 2 | 0.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 4 | 0.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 6 | 0.9 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 5 | 0.9 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 1 | 0.9 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 3 | 0.8 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 2 | 1.1 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 6 | 0.8 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 5 | 0.9 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 4 | 1.0 units on a scale | Standard Error 0.3 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 1 | 0.9 units on a scale | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaire (Satiety) Week 3 | 0.9 units on a scale | Standard Error 0.2 |
Secondary
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).
Time frame: 6 weeks
Population: Participants who completed all study requirements were included in the baseline analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 1 | 0.9 log CFU/g | Standard Error 0.1 |
| Placebo | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 6 | 1.6 log CFU/g | Standard Error 0.1 |
| Placebo | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 5 | 1.1 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 1 | 0.9 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 6 | 1.3 log CFU/g | Standard Error 0.2 |
| B. Subtilis R0179 (0.1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 5 | 4.6 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 5 | 5.6 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 1 | 0.9 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (1 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 6 | 0.8 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 1 | 1.2 log CFU/g | Standard Error 0.2 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 6 | 2.1 log CFU/g | Standard Error 0.1 |
| B. Subtilis R0179 (10 Billion CFU) | Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | GI Viability of Bacillus Spores Week 5 | 6.4 log CFU/g | Standard Error 0.1 |