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

January 27, 2026 updated by: Supplement Formulators, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33304
        • Recruiting
        • Life Extension Clinical Research, Inc.
        • Principal Investigator:
          • Andrew Swick, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female, age 25-70 years
  2. Body mass index 18.5-34.9 kg/m2
  3. 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
  4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
  5. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
  6. Weight stable for the past six months (±6 lbs.)
  7. Willing and able to give written informed consent
  8. Ability to communicate and read in English
  9. Ability to comply with study requirements

Exclusion Criteria:

  1. Currently participating in another clinical research study
  2. Pregnant, planning pregnancy, or breastfeeding
  3. Unable to swallow capsules, tablets, or softgels
  4. 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.
  5. Typically goes longer than 3 days without a bowel movement
  6. 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
  7. Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
  8. Planning to undergo a major medical procedure or surgical event within the next 30 days
  9. Currently being treated for any infectious disease
  10. 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)
  11. Smoking or use of nicotine products daily within 30 days prior to screening
  12. Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
  13. 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)
  14. Having donated blood or received a blood/plasma transfusion within 30 days before baseline
  15. History of a major change in dietary habits within the past 1 month
  16. Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
  17. Currently taking any laxatives on a daily basis
  18. Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
  19. On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
  20. History of oral or IV antibiotic use within the past 3 months prior to Baseline
  21. 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
  22. 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
  23. Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
  24. Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
  25. Currently experiencing or previously having a parasitic infection within the past 3 months
  26. Currently experiencing or having a history of severe endometriosis
  27. History of gastrointestinal surgery, which might influence gastrointestinal function
  28. 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Active Comparator: Butyrate + Polyphenol Formulation
Dietary supplement: Butyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS) version
Time Frame: 14 days
Change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. The responses to the questions range from no discomfort at all to very severe discomfort which would indicate a worse outcome
14 days
Gut Microbiome Stool Test
Time Frame: 14 days
Change in the Gut Microbiome (strain level, functional metrics, taxonomy abundance and composition) from baseline
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digestion-Associated Quality of Life Questionnaire (DQLQ)
Time Frame: 14 days
Change in the Digestion-Associated Quality of Life Questionnaire (DQLQ) from baseline. The lower score indicates an improved outcome.
14 days
Visual Analogue Scale (VAS) of abdominal pain
Time Frame: 14 days
Change in the Visual Analogue Scale (VAS) of abdominal pain from baseline. The lower the value indicates an improved outcome.
14 days
Bristol Stool Form Scale (BSFS)
Time Frame: 14 days
Change in the stool form from baseline. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
14 days
Gastrointestinal -Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Time Frame: 14 days
Change in the Gastrointestinal-Global Assessment of Improvement Scale (Gastrointestinal-GAI) from baseline. The responses range from substantially worse to substantially improved would indicate an improved outcome.
14 days
World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame: 14 days
Change in the World Health Organization Quality of Life (WHOQOL-BREF) from baseline. The higher score indicates a better perceived quality of life for each domain.(physical health, psychological health, social relationship, environment)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Andrew Swick, PhD, Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

April 26, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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