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 range
25 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
. 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.
. 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