Status:
RECRUITING
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
Lead Sponsor:
Supplement Formulators, Inc.
Conditions:
Gut Health
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief 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 sel...
Detailed Description
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals. Participants wi...
Eligibility Criteria
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
- Ability to comply with study requirements
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.
- 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
- Currently experiencing or having a history of severe endometriosis
- History of gastrointestinal surgery, which might influence gastrointestinal function
- History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator/Sub-I, would interfere with the interpretation of the study results and preclude participation in the study -
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT07371975
Start Date
October 16 2025
End Date
July 30 2026
Last Update
January 29 2026
Active Locations (1)
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1
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States, 33304