Actively Recruiting
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Led by Supplement Formulators, Inc. · Updated on 2026-01-29
124
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 25-70 years
- Body mass index between 18.5 and 34.9 kg/m2
- GSRS-IBS score of 21 or higher (for moderate or severe symptoms); mild symptoms may be included at investigator discretion
- Experiencing at least three of the following weekly: gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation
- Healthy based on medical history without chronic disease unless permitted by investigator
- Stable weight for past six months (±16 lbs)
- Willing and able to provide written informed consent
- Ability to communicate and read in English
- Ability to comply with study requirements
You will not qualify if you...
- Currently participating in another clinical research study
- Pregnant, planning pregnancy, or breastfeeding
- Unable to swallow capsules, tablets, or softgels
- Male and females of childbearing potential unwilling to use contraception from screening through 30 days after study
- Going longer than 3 days without a bowel movement
- Diagnosis of cardiovascular disease, abnormal ECG history, diabetes, or cancer (except non-melanoma skin cancer) within past 5 years
- Recent medical or surgical event in last 5 years requiring ongoing monitoring
- Planning major medical procedure or surgery within next 30 days
- Being treated for any infectious disease
- Consuming more than 6 (women) or 10 (men) standard alcoholic drinks per week
- Daily smoking or nicotine use within 30 days prior to screening
- Use of recreational drugs including THC within past 14 days
- History of intolerance or allergy to product ingredients
- Donated blood or received transfusion within 30 days before baseline
- Major dietary changes in past month
- Taking supplements with butyrate, tributyrin, or polyphenols unwilling to stop during study
- Daily use of laxatives
- Started GLP-1 medication within 3 months before screening
- Stable dose of proton pump inhibitors within 3 months before screening
- Oral or IV antibiotic use within 3 months before baseline
- Unwilling to refrain from gastrointestinal medications or supplements unless stable for over 3 months
- History or current diagnosis of gastrointestinal diseases including IBD, Crohn's, Ulcerative Colitis, Celiac disease, or GI cancer
- Currently treated for Irritable Bowel Syndrome
- Recent gastrointestinal infection or food poisoning within past month
- Parasitic infection within past 3 months
- Severe endometriosis
- History of gastrointestinal surgery affecting function
- Any significant diagnosis or condition interfering with study participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33304
Actively Recruiting
Research Team
S
Steven Hirsh
CONTACT
B
Barbara Martinez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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