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Simpler h. pylori treatment could reduce antibiotic use

NCT ID NCT07624422

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a simpler two-drug treatment (vonoprazan plus one antibiotic) works as well as a three-drug treatment (vonoprazan plus two antibiotics) for H. pylori infection. About 150 adults with confirmed H. pylori will take either regimen for 14 days. The main goal is to see how many people are cured of the infection, while also tracking side effects and how well patients follow 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 (a stomach acid reducer) combined with antibiotics (amoxicillin, levofloxacin, tinidazole)
What this could lead to
If successful, this could show that a simpler, two-drug regimen is as effective as a three-drug regimen for treating H. pylori, potentially reducing side effects and antibiotic resistance.
What could go wrong
This is a small, early-stage trial (phase 4) with only 150 participants. The results may not apply to everyone, and the simpler regimen might not work as well in real-world settings.

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 150 people

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

Expected to start

Nov 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 80 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: * Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed) * Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test * Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy) * Willing and able to provide written informed consent * Willing to adhere to the 14-day treatment regimen and follow-up visits * For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during the treatment period Exclusion Criteria: * History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin/cephalosporin * Previous H. pylori eradication therapy (if study is for first-line treatment) * Active gastrointestinal bleeding or perforation * Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR \< 30 mL/min/1.73m²) * Pregnancy or breastfeeding * Concurrent use of medications with significant drug-drug interactions (e.g., warfarin, phenytoin, digoxin, atazanavir, rilpivirine) * Malignancy or any life-threatening condition with life expectancy \< 6 months * Participation in another interventional trial within 30 days prior to enrollment * Any condition that, in the investigator's opinion, precludes safe participation or adherence to the protocol

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Conditions

The condition(s) this trial relates to.

gastritis Helicobacter pylori infectious disease peptic ulcer disease

As listed by the trial registrant

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

Gastritis Helicobacter pylori infection Peptic ulcer disease

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • General Assembly of Damascus Hospital

    Damascus, Syria

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