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Can a probiotic help knock out Hard-to-Treat stomach bugs?

NCT ID NCT07139366

Disease control Sponsor: Yongquan Shi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding a probiotic called Saccharomyces boulardii to a standard antibiotic cocktail helps clear Helicobacter pylori infections that didn't respond to earlier treatments. About 1,248 adults who have failed prior H. pylori therapy will be randomly assigned to get either the probiotic plus antibiotics or antibiotics alone for 14 days. The main goal is to see if the probiotic improves eradication rates and reduces side effects.

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) combined with bismuth, esomeprazole, tetracycline, and furazolidone (antibiotics and acid reducer)
What this could lead to
If it works, this could offer a more effective and safer way to treat H. pylori infections that haven't cleared with previous treatments, reducing the risk of ulcers and stomach cancer.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the probiotic's added benefit is uncertain. Side effects like headache, dizziness, and stomach issues are possible.

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 1,248 people

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

Started

Oct 2025

Expected to finish

Sep 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 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 between 18\~75, both gender. * Patients who had failed H.pylori eradication therapies . * Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. Exclusion Criteria: * Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori. * Contraindications to study drugs. * Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. * Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening). * Pregnant or lactating women. * Underwent upper gastrointestinal Surgery. * Dysphagia. * Evidence of bleeding or iron efficiency anemia. * A history of malignancy. * Drug or alcohol abuse history in the past 1 year. * Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). * Mental disorder. * Enrolled in other clinical trials in the past 3 months. * Refuse to sign informed consent.

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Conditions

The condition(s) this trial relates to.

dyspepsia gastric cancer gastric neoplasm gastritis Helicobacter pylori infectious disease peptic ulcer disease

As listed by the trial registrant

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

Dyspepsia Gastric cancer Gastritis Helicobacter pylori infection Peptic ulcer

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

  • Xijing Hosipital of Digestive Disease

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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