Healthy
Conditions
Keywords
safety, tolerability
Brief summary
The purpose of this research study is to determine the effects of the probiotic, Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria and blood biomarkers in healthy individuals.
Detailed description
Healthy adult volunteers from 18-50 years of age will be recruited through the University of Florida and randomly distributed into two groups. This study is divided into 3 phases: baseline, intervention (study treatment) and washout. Participants will receive either the probiotic or placebo during the intervention phases. During the baseline phase, blood and fecal samples will be collected about 1 week before intervention initiation. On the day of a scheduled blood draw, the participant will need to arrive fasted overnight, and a light breakfast will be provided after blood draw. Starting on day 1 of the intervention phase, a second baseline blood sample will be collected and the participant will begin the study intervention (probiotic or placebo). Participants will consume 1 capsule (probiotic or placebo) daily for 8 weeks, and blood and stool samples will be collected and processed (on or around weeks 2, 4 and 8 of the intervention phase). A Fisher Scientific commode specimen collection system will be provided for stool collections. The stool collection kit may be taken home (participants will be asked to drop off the stool within 4 hours of defecation) for fecal sample collection or may use the restroom in the clinical lab at the Food Science and Human Nutrition Building in which kits will be provided for use. In the wash-out phase, participants will not consume the capsule (either the probiotic or placebo), but will provide blood and stool samples (on or around week 12). Throughout the study, participants will provide a total of 5 stool samples and 6 blood samples. Participants will be asked to complete daily and weekly questionnaires throughout all phases of the study, which will ask about quality of life (physical functioning, mental functioning, level of sleep, etc.), gastrointestinal function, and dietary intake. These assessments will be self-reported via online questionnaires. In the event that internet access is not available for a portion of the study, paper copies of the questionnaires may be provided.
Interventions
BIOLOGICALL. johnsonii N6.2
L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks
BIOLOGICALPlacebo
Encapsulated starch placebo administered for 8 weeks
Sponsors
Juvenile Diabetes Research Foundation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* To participate in the study individuals must * be 18-50 years old. * be willing to complete multiple questionnaires via computer. * be willing to take the probiotic or placebo capsule daily for 8 weeks. * be willing to provide 1 stool during weeks 0, 2, 4, 8 and 12 of the study. * be willing to provide blood samples at weeks -1, 0, 2, 4, 8 and 12 of the study. * have daily access to a computer with internet access for the entire 13-wk study. * be willing to provide a social security number
Exclusion criteria
* To participate in the study individuals must NOT * currently take medications for constipation, diarrhea or psychological disorders (depression, anxiety, insomnia etc.). * have taken antibiotics within the past four weeks prior to randomization. * currently take probiotic supplements and do not want to discontinue a minimum of two weeks prior to the study * have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), chronic disease like diabetes or kidney disease, immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, transplant patient etc.) * currently receive medical treatment for stress induced symptoms/disorders * be a current smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events | 13 weeks | The number of participants reporting Adverse Events was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Measure of Blood Chemistry Profiles | 13 weeks | Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Probiotic L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks
L. johnsonii N6.2: L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks | 21 |
| Placebo Encapsulated starch placebo administered for 8 weeks
Placebo: Encapsulated starch placebo administered for 8 weeks | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Probiotic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age, Continuous | 21 years | 23 years | 21 years |
| Region of Enrollment United States | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 2 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Number of Participants Reporting Adverse Events
The number of participants reporting Adverse Events was reported.
Time frame: 13 weeks
Population: Subjects completing the probiotic and the placebo intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotic | Number of Participants Reporting Adverse Events | 1 Participants |
| Placebo | Number of Participants Reporting Adverse Events | 2 Participants |
Secondary
Composite Measure of Blood Chemistry Profiles
Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.
Time frame: 13 weeks
Population: Subjects completing intervention and final blood draw after 4 week washout period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Probiotic | Composite Measure of Blood Chemistry Profiles | 0 events |
| Placebo | Composite Measure of Blood Chemistry Profiles | 0 events |