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Could probiotics help antibiotics work better for gut bacteria overgrowth?

NCT ID NCT07426705

Disease control Sponsor: Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether adding a specific probiotic (containing Enterococcus faecium and Bacillus subtilis) to the antibiotic rifaximin can improve treatment for small intestinal bacterial overgrowth (SIBO), a condition that causes bloating, pain, and diarrhea. About 100 adults with SIBO and irritable bowel syndrome will get either the probiotic or a placebo after antibiotic therapy. The goal is to see if the probiotic helps clear the overgrowth and prevents it from coming back.

What this could mean

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

Active substance
multispecies probiotic containing Enterococcus faecium and Bacillus subtilis
What this could lead to
If it works, this could point toward a way to improve antibiotic treatment for SIBO and lower the chance of symptoms coming back.
What could go wrong
This is a small, early-phase trial with only 100 participants, so results may not apply to everyone. Probiotics can sometimes cause bloating or gas, and the added benefit over antibiotic alone is 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ≥18 years. * Meets Rome IV criteria for irritable bowel syndrome. * Written informed consent to participate in the study. Exclusion Criteria: * Lack of cooperation with investigators. * Age \>75 years. * Need for modification of gastrointestinal treatment during the study. * Use of antibiotics within 4 weeks before screening. * Use of probiotics within 7 days before screening. * Endoscopic examination within 6 weeks before screening or during the study without investigator approval. * History of abdominal surgery. * Crohn's disease, ulcerative colitis, microscopic colitis, celiac disease, cystic fibrosis, chronic pancreatitis, liver cirrhosis, or end-stage renal disease. * Low FODMAP diet within 4 weeks before screening. * Pregnancy or breastfeeding. * Lactulose intolerance.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome small intestinal bacterial overgrowth

As listed by the trial registrant

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

IBS Small intestinal bacterial overgrowth syndrome (SIBO)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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