Gut Health
Conditions
Keywords
Gastrointestinal discomfort, Abdominal pain, Gas, Bloating, Diarrhea, Constipation, Heartburn, Abdominal discomfort
Brief summary
The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms
Detailed description
This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms. Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be scheduled remote video calls during the study. The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.
Interventions
DIETARY_SUPPLEMENTButyrate Formulation
Butyrate Formulation capsule: Take daily
DIETARY_SUPPLEMENTButyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation capsule: Take daily
DIETARY_SUPPLEMENTPlacebo
Placebo: Take daily
Sponsors
Compound Solutions Inc.
Supplement Formulators, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ambulatory, male or female, 21-70 years of age 2. A BMI of 18.5 -34.9 3. . Experiences at least three conditions involving gastrointestinal health on a weekly basis 4. Are comfortable fasting overnight 5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days 6. Considered to be generally healthy on the basis of medical history 7. Willing to follow study instructions, including compliance with the study procedures and requirements
Exclusion criteria
1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick 2. Currently on a galactose/lactose restricted diet 3. Having taken proton pump inhibitors within the past 3 months 4. History of oral antibiotic use within the past 3 months 5. Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters 6. A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study 7. Current or previous history of diabetes 8. History of a major change in dietary habits with the past 1 month 9. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose 10. Women who are lactating, pregnant or planning pregnancy within the next two months 11. Having donated blood or received a blood transfusion within 30 days before screening 12. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Gut Microbiome | 28 days | Assessment of the median change in the results of the Gut Microbiome from baseline. |
| The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version | 28 days | Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Permeability Test | 28 days | Assessment of the median change in the results of the Intestinal Permeability Test from baseline. |
| Digestion - Associated Quality of Life Questionnaire (DQLQ) | 28 days | Assessment of the median change in the responses on the Digestion- Associated Quality of Life Questionnaire (DQLQ) from baseline. The questionnaire has questions related to digestive events and experiences in the last seven days evaluated on a scale from never (0%) to always (100%). The lower score indicates an improved outcome. |
| Visual Analogue Scale (VAS) of abdominal pain | 28 days | Assessment of the median change in the responses on the Visual Analogue Scale questionnaire of abdominal pain from baseline. This scale indicates the response to the intensity of abdominal pain at the time evaluated on a scale from 0 (no pain) to 10 (severe pain). The lower the value indicates an improved outcome. |
| Gut Barrier Panel | 28 days | Assessment of the median change in the results of the Panel for the Gut Barrier from baseline. |
| Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI) | 28 days | Assessment of the median change in the responses on the Gastrointestinal- Global Assessment of Improvement Scale from baseline. This scale indicates the status of the gastrointestinal symptoms over the past 7 days. The responses range from substantially worse to substantially improved which would indicate an improved outcome. |
| Short Form-36 Health Survey (SF-36 Health Survey) | 28 days | Assessment of the median change in the responses to the SF-36 Health Survey from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome. |
| Bristol Stool Form Scale (English for United States) | 28 days | Assessment of the median change in the stool form from baseline. This is related to asking the subject what their stool looked like each time they had a bowel movement for the day. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types. |
| Short Chain Fatty Acids (SCFA) | 28 days | Assessment of the median change in the results of the Short Chain Fatty Acid Analysis from baseline. |
Countries
United States
Outcome results
None listed