New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool (HEPYPRIM)

August 28, 2026 updated by: Poitiers University Hospital

Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool

In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Frontenay-Rohan-Rohan, France
        • Vincent HELIS
      • Jarnac-Champagne, France
        • philippe BRAVIN
      • La Mothe-Saint-Héray, France
        • Gwenaelle FARCY
      • La Mothe-Saint-Héray, France
        • Marie ROCHEPEAU
      • La Roche-Posay, France
        • Claude SAPIN
      • Mignaloux-Beauvoir, France
        • Lise BLANCHARD
      • Nueil-les-Aubiers, France
        • ARCHAMBAULT Pierrick
      • Pont Labbe Darnoult, France
        • Marc CHABANNE
      • Saint-Germain-de-Marencennes, France
        • Elodie POUPIN
      • Saint-Jean-d'Angély, France
        • Vincent JEDAT
      • Tonnay-Charente, France
        • Christophe BONNET
      • Vaux-sur-Mer, France
        • ANDRIEUX Marine
      • Vaux-sur-Mer, France
        • FRECHE Bernard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Person over 18 years old
  • Patient affiliated or beneficiary of a social security scheme.
  • Informed consent signed by the patient after clear and fair information about the study
  • Patient registered on the list of patients who signed a doctor's statement with the investigating doctor.

  • Patient with an indication for research and treatment of an Hp infection according to National Health Authority (HAS) recommendations:

    1. Suffering from (at least one) : Chronic dyspepsia; Iron deficiency anemia without a found cause or resistant to iron supplementation; Vitamin B12 deficiency without a found cause; familial gastric cancer DCDS; Immunological thrombocytopenic purpura in adulthood; history of peptic ulcers or precancerous lesions that have not been eradicated; Long-term consumption of NSAIDs; Long-term PPI consumption.

      or

    2. Patient who received Hp eradication treatment without eradication control. or

    3. Patient with risk factors for gastric cancer: person related to a patient who has had stomach cancer (parents, brothers / sisters, children).

      or

    4. Patient with a syndrome of predisposition to digestive cancers (Hereditary non-polyposis colorectal carcinoma cancer HNPCC / Lynch syndrome).

      or

    5. Patient who has had a partial gastrectomy or endoscopic treatment of gastric cancerous lesions.

      or

    6. Patient with pre-neoplastic gastric lesions (severe atrophy and / or intestinal metaplasia, dysplasia).

      or

    7. Patient who has already undergone an endoscopy with detection of Hp but without antibiotic sensitivity test (biopsy not addressed in bacteriology) and for whom we want to undergo a guided treatment.

Exclusion Criteria:

  • Patient benefiting from enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations.
  • Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).

Exclusion criteria related to non-compliance with ambivalence:

  • Allergy to amoxicillin (suspected or documented).
  • Contraindication to eso-gastro-duodenal fibroscopy and biopsies.
  • Use of antibiotic within 15 days before enrolment.
  • Patient with an indication to perform an endoscopy of the upper digestive system in Emergency according to the criteria of "the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE II)": upper gastrointestinal hemorrhage; acute deglobulization without digestive hemorrhage externalized; ingestion of caustics; acute dysphagia or ingestion of foreign bodies.
  • Participating another interventional trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: National Health Authority (HAS) strategy control
Patients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication.
Diagnostic test: PCR test in the stool
Patients receive a prescription for a stool self-collection kit.
Diagnostic test: Hp serology and gastroscopy
Patients receive a prescription for an Hp serology. A positive serological test will lead to a gastroscopy with biopsies for histology/pathological and bacteriological analyses.
Experimental: new strategy experimental
Patients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication.
Diagnostic test: PCR test in the stool
Patients receive a prescription for a stool self-collection kit.
Diagnostic test: Hp serology and gastroscopy
Patients receive a prescription for an Hp serology. A positive serological test will lead to a gastroscopy with biopsies for histology/pathological and bacteriological analyses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with a negative urea breath test (proof of Hp eradication)
Time Frame: up to 4 months after inclusion
Urea breath test is carried out 6 weeks after the end of treatment
up to 4 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPYPRIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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