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Probiotic may counteract gut bacteria changes from common heartburn drug

NCT ID NCT05517928

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether taking the probiotic Lactobacillus rhamnosus GG (found in Culturelle) can prevent or reverse changes in gut bacteria caused by the acid reflux drug omeprazole. Researchers will give 30 healthy adults omeprazole plus either the probiotic or a placebo for several weeks, then compare stool samples to see how gut microbes differ. The goal is to understand if probiotics can help maintain a healthy gut during PPI therapy.

What this could mean

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

Active substance
Lactobacillus rhamnosus GG (probiotic) and omeprazole (acid reflux drug)
What this could lead to
If it works, this could point toward a simple probiotic supplement to protect gut health in people who need long-term acid reflux medication.
What could go wrong
This is a very small, early exploratory study in healthy people, not patients. It only measures gut bacteria changes, not health outcomes, so real benefits remain uncertain.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.). * Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire. * Only those with an absence of symptoms will eligible to participate. Exclusion Criteria: * For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy). * Chronic daily use of medications affecting GI secretion or motor function. * The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease. * Pregnancy.

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As listed by the trial registrant

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

Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

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