Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

January 9, 2026 updated by: Supplement Formulators, Inc.

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms.

Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be scheduled remote video calls during the study.

The study subjects will complete assessment tools that include a Rating Scale for Gastrointestinal Symptoms, Quality of Life Questionnaire for Digestion, Visual Analogue Scale of Abdominal Pain, Stool Form Scale, Global Assessment of Improvement Scale-Gastrointestinal and the Short Form-36 Health Survey (SF-36). Laboratory testing will include an assessment of Gut Microbiome, analysis of Short Chain Fatty Acids, a panel for the Gut Barrier and Intestinal Permeability.

Study Type

Interventional

Enrollment (Actual)

143

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 Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33304
        • Life Extension Clinical Research, Inc.

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. Ambulatory, male or female, 21-70 years of age
  2. A BMI of 18.5 -34.9
  3. . Experiences at least three conditions involving gastrointestinal health on a weekly basis
  4. Are comfortable fasting overnight
  5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days
  6. Considered to be generally healthy on the basis of medical history
  7. Willing to follow study instructions, including compliance with the study procedures and requirements

Exclusion Criteria:

  1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick
  2. Currently on a galactose/lactose restricted diet
  3. Having taken proton pump inhibitors within the past 3 months
  4. History of oral antibiotic use within the past 3 months
  5. Current or previous history of gastrointestinal disease, cancer, infection or surgery that may interfere with the outcome parameters
  6. 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
  7. Current or previous history of diabetes
  8. History of a major change in dietary habits with the past 1 month
  9. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose
  10. Women who are lactating, pregnant or planning pregnancy within the next two months
  11. Having donated blood or received a blood transfusion within 30 days before screening
  12. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening

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
Active Comparator: Butyrate Formulation
Butyrate Formulation: Take daily in the morning with 8 oz. (240ml) of water
Dietary supplement: Butyrate Formulation
Butyrate Formulation capsule: Take daily
Active Comparator: Butyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation: Take daily in the morning with 8 oz. (240ml) of water
Dietary supplement: Butyrate + Polyphenol Formulation
Butyrate + Polyphenol Formulation capsule: Take daily
Placebo Comparator: Placebo
Placebo: Take daily in the morning with 8 oz. (240ml) of water
Dietary supplement: Placebo
Placebo: Take daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Gut Microbiome
Time Frame: 28 days
Assessment of the median change in the results of the Gut Microbiome from baseline.
28 days
The Gastrointestinal Symptom Rating Scale (GSRS) Irritable Bowel Syndrome (IBS) version
Time Frame: 28 days
Assessment of the median change in the responses on the Gastrointestinal Symptom Rating Scale-IBS from baseline. This scale has questions about how you have been feeling and what it has been like in the past week. The responses to each question range from no discomfort at all to very severe discomfort which would indicate a worse outcome.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Barrier Panel
Time Frame: 28 days
Assessment of the median change in the results of the Panel for the Gut Barrier from baseline.
28 days
Short Chain Fatty Acids (SCFA)
Time Frame: 28 days
Assessment of the median change in the results of the Short Chain Fatty Acid Analysis from baseline.
28 days
Intestinal Permeability Test
Time Frame: 28 days
Assessment of the median change in the results of the Intestinal Permeability Test from baseline.
28 days
Digestion - Associated Quality of Life Questionnaire (DQLQ)
Time Frame: 28 days
Assessment of the median change in the responses on the Digestion- Associated Quality of Life Questionnaire (DQLQ) from baseline. The questionnaire has questions related to digestive events and experiences in the last seven days evaluated on a scale from never (0%) to always (100%). The lower score indicates an improved outcome.
28 days
Visual Analogue Scale (VAS) of abdominal pain
Time Frame: 28 days
Assessment of the median change in the responses on the Visual Analogue Scale questionnaire of abdominal pain from baseline. This scale indicates the response to the intensity of abdominal pain at the time evaluated on a scale from 0 (no pain) to 10 (severe pain). The lower the value indicates an improved outcome.
28 days
Bristol Stool Form Scale (English for United States)
Time Frame: 28 days
Assessment of the median change in the stool form from baseline. This is related to asking the subject what their stool looked like each time they had a bowel movement for the day. There are 7 various stool types to choose ranging from Type 1 to Type 7. Types 3 or 4 are the preferred types.
28 days
Gastrointestinal- Global Assessment of Improvement Scale (Gastrointestinal-GAI)
Time Frame: 28 days
Assessment of the median change in the responses on the Gastrointestinal- Global Assessment of Improvement Scale from baseline. This scale indicates the status of the gastrointestinal symptoms over the past 7 days. The responses range from substantially worse to substantially improved which would indicate an improved outcome.
28 days
Short Form-36 Health Survey (SF-36 Health Survey)
Time Frame: 28 days
Assessment of the median change in the responses to the SF-36 Health Survey from baseline. This is a 36-item questionnaire that covers eight domains including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The scores from each domain can range from 0 to 100. The higher the scores for each domain indicates a better outcome.
28 days

Collaborators and Investigators

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

Sponsor

Supplement Formulators, Inc.

Collaborators

Compound Solutions Inc.

Investigators

  • Principal Investigator: Andrew Swick, Ph.D, 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 31, 2023

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL115

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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