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Could a Two-Drug cocktail beat the standard Four-Drug regimen for stomach bug?

NCT ID NCT07179159

Disease control Sponsor: Yanqing Li 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 14-day course of just two medications (vonoprazan and amoxicillin) works as well as the usual four-drug combination for eradicating H. pylori, a bacteria that can cause stomach ulcers and cancer. About 372 adults with a confirmed H. pylori infection who have never been treated before will be randomly assigned to one of three groups. The main goal is to see how many people are cured of the infection, and the study also tracks side effects and how well patients stick to the treatment.

What this could mean

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

Active substance
vonoprazan and amoxicillin (dual therapy) or vonoprazan, amoxicillin, levofloxacin or clarithromycin, and bismuth (quadruple therapy)
What this could lead to
If successful, this could offer a simpler, shorter treatment for H. pylori infection with fewer side effects than current standard therapy.
What could go wrong
This is a mid-stage trial with 372 participants, so results may not apply to everyone. The dual therapy might not be as effective as the quadruple therapy, and side effects are still 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 372 people

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

Started

Sep 2025

Expected to finish

Dec 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 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 18-70 years, male or female 2. Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue) 3. No prior Helicobacter pylori eradication therapy Exclusion Criteria: 1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours 2. Active gastrointestinal bleeding 3. History of upper gastrointestinal surgery 4. History of drug hypersensitivity 5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks 6. Pregnant or lactating women 7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use 8. Individuals unable or unwilling to provide 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 places running it

    2 sites. 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

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, China

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