About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Butyrate + Polyphenol Formulation
- Placebo