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Can a Two-Drug combo beat a stubborn stomach bug?

NCT ID NCT07757919

Disease control Sponsor: Qilu Hospital of Shandong University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial compares a 14-day course of vonoprazan plus minocycline against two other dual therapies (vonoprazan with amoxicillin or tetracycline) for eradicating Helicobacter pylori, a common stomach infection linked to ulcers and cancer. About 492 adults who have never been treated for H. pylori will be randomly assigned to one of the three regimens. The study tracks how well each treatment clears the infection (confirmed by a breath test six weeks later), as well as side effects and how well participants stick to the medication schedule.

What this could mean

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

Active substance
Vonoprazan-minocycline dual therapy (vonoprazan fumarate tablets plus minocycline capsules)
What this could lead to
If successful, this could offer a simpler, shorter, and possibly better-tolerated antibiotic option for clearing H. pylori infections, reducing the risk of stomach ulcers and cancer.
What could go wrong
This is a phase 4 trial, but the new combination may not be as effective as existing treatments, and antibiotics can cause side effects like nausea or diarrhea. Results may not apply to all patients.

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 492 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 65 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: * Aged 18-65 years, male or female. * Helicobacter pylori-infected patients with positive ¹³C/¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test. * No prior history of Helicobacter pylori eradication therapy. Exclusion Criteria: * Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc. * Active gastrointestinal bleeding. * History of upper gastrointestinal surgery. * History of allergy to study medications. * Use of antibiotics or bismuth agents within 1 month, or acid-suppressive agents within 2 weeks. * Pregnant or lactating women. * Presence of other behaviors that may increase disease risks, such as heavy alcohol consumption, drug abuse, etc. * Participation in other clinical trials within 3 months. * Subjects unable or unwilling to provide written informed consent.

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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 infections

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

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More trials for these conditions

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