A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gut Health

In brief

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.

Key facts

Study ID

NCT07371975

Run by

Supplement Formulators, Inc.

People needed

124

Starts

2025-10-16

Expected to finish

2026-07-30

Last updated by the study team

2026-01-29

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Ability to comply with study requirements

You may not qualify if…

• 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.
• 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
• Currently being treated for any infectious disease
• Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
• Smoking or use of nicotine products daily within 30 days prior to screening
• Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
• History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
• Having donated blood or received a blood/plasma transfusion within 30 days before baseline
• History of a major change in dietary habits within the past 1 month
• Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
• Currently taking any laxatives on a daily basis
• Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
• On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
• History of oral or IV antibiotic use within the past 3 months prior to Baseline
• Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for > 3 months before Screening and unlikely to change) unless in the judgment of the PI/Sub-I
• Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer
• Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
• Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
• Currently experiencing or previously having a parasitic infection within the past 3 months

Where it is running

• Life Extension Clinical Research, Inc. — Fort Lauderdale, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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