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Could a probiotic yeast rival antibiotics for gut bloating and diarrhea?

NCT ID NCT07815548

Disease control Sponsor: Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

Researchers are testing whether a probiotic yeast, Saccharomyces boulardii, works as well as the antibiotic rifaximin for adults with small intestinal bacterial overgrowth (SIBO) who have bloating and diarrhea. The trial enrolls 222 people aged 18 to 70 with a positive breath test for SIBO. Participants take one of the two treatments by mouth twice daily for two weeks, and researchers track symptom relief right after treatment and one month later.

What this could mean

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

Active substance
Saccharomyces boulardii, a probiotic yeast, compared with rifaximin, an antibiotic
What this could lead to
If the probiotic works about as well as the antibiotic, it could offer a non-antibiotic option for people with SIBO, especially those who cannot take antibiotics or need long-term care.
What could go wrong
The probiotic may not match the antibiotic's effect, and symptom relief can vary widely between people. The trial lasts two weeks with a one-month follow-up, so it cannot show whether benefits last longer.

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 222 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 to 70 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: 1. Aged between 18 and 70 years, male or female. 2. Presenting with chief complaints of abdominal distension and/or diarrhea. 3. Diagnosis of small intestinal bacterial overgrowth (SIBO) confirmed by positive hydrogen-methane breath test. Exclusion Criteria: 1. Pregnant, puerperal, or breastfeeding women. 2. Prior history of gastrointestinal malignancy or gastrointestinal surgery. 3. Previously diagnosed or suspected lactose intolerance. 4. Severe or extremely abnormal anxiety-depression scale scores. 5. Confirmed extra-digestive system diseases, including urinary system diseases (e.g., chronic kidney disease), immune system diseases (e.g., scleroderma), nervous system diseases (e.g., Parkinson's disease), and endocrine system diseases (e.g., diabetes mellitus). 6. Use of antibiotics or microecological preparations within 2 weeks before enrollment; receiving endoscopy, enema, or colonic barium-air contrast examination within 2 weeks before enrollment; use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, or antidepressants within 1 week before enrollment. 7. Known allergy to study medications. 8. Immunosuppressed hospitalized patients or hospitalized patients with immune impairment due to critical illness. 9. Unable or unwilling to provide written informed consent. 10. History of psychiatric disorders. 11. Any other conditions that render the subject inappropriate for participation in this study, as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

small intestinal bacterial overgrowth

As listed by the trial registrant

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

Small intestinal bacterial overgrowth syndrome (SIBO)

How to take part

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  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

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Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

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