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TerminatedNCT05495854HEPYPRIMUpdated Sep 1, 2026

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

An interventional study of PCR test in the stool and Hp serology and gastroscopy in Helicobacter Pylori Infection, sponsored by Poitiers University Hospital. Terminated at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Diagnostic

Why this study was terminated
The study was stopped due to recruitment difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • non-invasive diagnostic test
03

In context

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
245 participants (actual)

Study arms

  • 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 · Diagnostic Test: Hp serology and gastroscopy

  • 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 · Diagnostic Test: Hp serology and gastroscopy

Interventions

  • Diagnostic testPCR test in the stool

    Patients receive a prescription for a stool self-collection kit.

  • Diagnostic testHp 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.

06

What researchers measure

Primary outcomes

  1. Proportion of patients with a negative urea breath test (proof of Hp eradication)

    Urea breath test is carried out 6 weeks after the end of treatment

    Time frame: up to 4 months after inclusion

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Study locations

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

Publications

  • Pichon M, Freche B, Burucoa C. New Strategy for the Detection and Treatment of Helicobacter pylori Infections in Primary Care Guided by a Non-Invasive PCR in Stool: Protocol of the French HepyPrim Study. J Clin Med. 2022 Feb 22;11(5):1151. doi: 10.3390/jcm11051151. PubMed 35268242 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 24, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05495854
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Feb 3, 2023
Primary completion
Oct 20, 2025
Completion
Oct 20, 2025
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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