Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Perm… (NCT06419231) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms
United States143 participantsStarted 2023-10-31
Plain-language 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
Who can participate
Age range
21 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
. Ambulatory, male or female, 21-70 years of age
. A BMI of 18.5 -34.9
. . Experiences at least three conditions involving gastrointestinal health on a weekly basis
. Are comfortable fasting overnight
. Are able to complete study procedures for up to approximately 6 hours on 2 separate days
. Considered to be generally healthy on the basis of medical history
. Willing to follow study instructions, including compliance with the study procedures and requirements
Exclusion criteria
. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
. Currently on a galactose/lactose restricted diet
. Having taken proton pump inhibitors within the past 3 months
. History of oral antibiotic use within the past 3 months
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
Assessment of Gut Microbiome
Timeframe: 28 days
2
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
. Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
. 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
. Current or previous history of diabetes
. History of a major change in dietary habits with the past 1 month