A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated… (NCT07371975) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
United States124 participantsStarted 2025-10-16
Plain-language summary
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.
Who can participate
Age range25 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
✓. Weight stable for the past six months (±6 lbs.)
✓. Willing and able to give written informed consent
✓. Ability to communicate and read in English
Exclusion criteria
✕. 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.
What they're measuring
1
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
. Typically goes longer than 3 days without a bowel movement
✕. Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years
✕. Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
✕. Planning to undergo a major medical procedure or surgical event within the next 30 days