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Could a 7-Day cocktail beat h. pylori? new trial tests shorter fix

NCT ID NCT07232095

Disease control Sponsor: The First Affiliated Hospital with Nanjing Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 7-day combination of vonoprazan, high-dose amoxicillin, and bismuth can effectively eradicate H. pylori bacteria in the stomach. About 316 adults with a first-time H. pylori infection will be randomly assigned to either the 7-day triple therapy or a standard 14-day dual therapy. The goal is to see if the shorter regimen works just as well with fewer 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
Vonoprazan, Amoxicillin, and Bismuth
What this could lead to
If successful, this 7-day triple therapy could offer a shorter, effective first-line treatment for H. pylori infection, potentially improving patient compliance.
What could go wrong
This is a phase 4 trial, but the shorter regimen may still fail to achieve adequate eradication rates, and bismuth can cause side effects like dark stools or nausea.

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 316 people

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

Started

Jan 2026

Expected to finish

Jun 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 18 to 70 years, regardless of sex. 2. Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment. 3. Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment. 4. No prior H. pylori eradication therapy. 5. Written informed consent before participation. Exclusion Criteria: 1. Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth). 2. Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment. 3. Pregnant or lactating women. 4. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period. 5. Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy. 6. History of gastric or esophageal surgery. 7. Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.

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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

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

  • The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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