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New triple therapy may finally knock out tough stomach bug

NCT ID NCT05874544

Disease control Sponsor: Shanghai Jiao Tong University School of Medicine 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a three-drug combination containing rifabutin can wipe out Helicobacter pylori infections that didn't respond to earlier treatments. 360 adults who had failed prior therapy were randomly assigned to one of three regimens. The goal was to see which approach had the highest eradication rate six weeks after treatment ended.

What this could mean

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

Active substance
Rifabutin (antibiotic) combined with vonoprazan (acid reducer) and amoxicillin (antibiotic)
What this could lead to
If successful, this could provide a more effective rescue treatment for people with hard-to-treat H. pylori infections, reducing the risk of ulcers and stomach cancer.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all populations. Rifabutin can cause side effects like low white blood cell counts and may not work if resistance develops.

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

360 people

The number who actually took part.

Started

May 2023

Finished

Jan 2025

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: * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection and with previous treatment experience Exclusion Criteria: * subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * Previous history of tuberculosis * Allergy to any of the study drugs * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

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Conditions

The condition(s) this trial relates to.

Helicobacter pylori infectious disease

As listed by the trial registrant

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

Helicobacter pylori infection

Contacts and locations

Locations

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127, China

  • Shanghai Songjiang District Central Hospital

    Shanghai, Shanghai Municipality, China

  • The Second Affiliated Hospital of Zhejiang University school of Medicine

    Hangzhou, Zhejiang, China

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