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New dual therapy may simplify h. pylori treatment without losing effectiveness

NCT ID NCT06412588

Disease control Sponsor: Nanjing First Hospital, Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a two-drug combination (vonoprazan plus either amoxicillin or doxycycline) works as well as the standard four-drug bismuth quadruple therapy for eradicating H. pylori infection. 579 adults with H. pylori took one of three 14-day treatments. Researchers measured eradication rates, side effects, and how well patients followed the regimen. The goal is to find a simpler, safer, and more affordable treatment option.

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

579 people

The number who actually took part.

Started

Jun 2024

Finished

Jan 2026

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

Accepted

You do not need to have the condition being studied to take part.

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. Age 18-65 years old; 2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT; 3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year; 4. Voluntarily join this trial and sign the informed consent form. Exclusion Criteria: 1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.); 2. Patients with confirmed active peptic ulcer; 3. Patients who have received Helicobacter pylori eradication therapy within half a year; 4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment; 5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs; 6. History of esophageal or gastric surgery; 7. Pregnant or lactating women; 8. Alcoholism 9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease; 10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons; 11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

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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

  • NanJing Frist Hospital

    Nanjing, Jiangsu, 210006, China

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