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Could a simple supplement soothe your tummy troubles?

NCT ID NCT07371975

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study is testing whether a supplement containing butyrate and polyphenols can improve gut health and reduce digestive discomfort like bloating, gas, and abdominal pain. Researchers will enroll 124 adults aged 25-70 who report regular gut issues. Participants will take either the supplement or a placebo, and changes in symptoms and gut bacteria will be measured over time.

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 supplement
What this could lead to
If it works, this could point toward a natural supplement option for managing common gut symptoms like bloating and abdominal pain.
What could go wrong
This is an early-stage trial with no phase designation, so results may not be conclusive. The supplement may not outperform placebo, and benefits may vary widely between individuals.

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

124 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

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

25 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. 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 -

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Conditions

The condition(s) this trial relates to.

Abdominal Pain constipation disorder diarrheal disease Mucopolysaccharidosis IV

As listed by the trial registrant

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

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.