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Stomach biopsies could reveal Antibiotic-Resistant h. pylori without extra tests

NCT ID NCT07821294

Diagnosis Sponsor: Clinique Bizet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Helicobacter pylori is a common stomach infection, and doctors often treat it with clarithromycin. Resistance to this antibiotic is growing, so researchers want to know if a DNA test called qPCR can spot resistant infections using stomach biopsy tissue that is already collected and stored. The study includes 250 adults who have H. pylori confirmed by standard tissue tests. Researchers compare qPCR results with histology, immunohistochemistry, and bacterial PCR to see how well the new test performs and whether it could guide treatment choices.

What this could mean

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

Active substance
qPCR testing on stored stomach biopsy tissue
What this could lead to
If it works, doctors could check for clarithromycin resistance using biopsy tissue they already collect, without a separate culture or endoscopy.
What could go wrong
The test may miss cases or give unclear results on stored tissue, and it may not change treatment decisions in practice. This is an observational study, so it cannot prove that using the test improves patient outcomes.

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.

Participants

About 250 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

Aug 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.

Who is studied

Adults undergoing gastroscopy with gastric biopsies for suspected Helicobacter pylori infection. Participants must have confirmed H. pylori infection by histology and immunohistochemistry. Gastric biopsy samples will be analyzed by q-PCR on formalin-fixed paraffin-embedded (FFPE) tissue to evaluate detection of H. pylori and clarithromycin resistance-associated mutations.

Ages

18 years and older

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. * Ability to provide non-opposition to participate in the study. * Participants with suspected Helicobacter pylori infection requiring gastric biopsies during gastroscopy for H. pylori assessment by histopathology and bacteriology, including clarithromycin resistance testing by PCR. * Confirmed presence of Helicobacter pylori by histological examination and immunohistochemistry. Exclusion Criteria: * Minor participants. * Adults under legal protection, guardianship or curatorship. * Refusal to participate in the study. * Recent antibiotic therapy (\<4 weeks) that may affect bacterial load. * Recent proton pump inhibitor treatment (\<2 weeks). * Insufficient tissue quantity for complementary analyses. * Poor quality fixation or preservation of samples.

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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

    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

  • Benkessou

    Paris, 75016, France

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