The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.
Male or female, age 25-70 years
Body mass index 18.5-34.9 kg/m2
A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
Currently participating in another clinical research study
Pregnant, planning pregnancy, or breastfeeding
Unable to swallow capsules, tablets, or softgels
Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
Parallel
Butyrate + Polyphenol Formulation
Dietary supplementButyrate + Polyphenol Formulation
Placebo
Dietary supplementPlacebo
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
Gut Microbiome Stool Test
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
Digestion-Associated Quality of Life Questionnaire (DQLQ)
Change in the Digestion-Associated Quality of Life Questionnaire (DQLQ) from baseline. The lower score indicates an improved outcome.
Visual Analogue Scale (VAS) of abdominal pain
Change in the Visual Analogue Scale (VAS) of abdominal pain from baseline. The lower the value indicates an improved outcome.
Bristol Stool Form Scale (BSFS)
Change in the stool form from baseline. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Change in the Gastrointestinal-Global Assessment of Improvement Scale (Gastrointestinal-GAI) from baseline. The responses range from substantially worse to substantially improved would indicate an improved outcome.
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