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Gut health boost? butyrate and polyphenol supplements under study

NCT ID NCT06419231

Symptom relief Sponsor: Supplement Formulators, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tested two dietary supplements—a butyrate formulation and a butyrate plus polyphenol formulation—against a placebo in 143 adults with frequent gut issues. The goal was to see if these supplements improve gut health, reduce gut permeability, and ease digestive symptoms. Participants took capsules daily and were monitored for changes in gut microbiome, symptoms, and other markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Butyrate and polyphenol dietary supplements
What this could lead to
If effective, these supplements could offer a natural way to improve gut health and ease digestive discomfort.
What could go wrong
This is a small, completed trial with no phase designation, so results are preliminary. Supplements are not regulated like drugs, and benefits may be modest or not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

143 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Abdominal Pain constipation disorder diarrheal disease Heartburn Mucopolysaccharidosis IV

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gut health

Contacts and locations

Locations

  • Life Extension Clinical Research, Inc.

    Fort Lauderdale, Florida, 33304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.