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

NCT05495854 | Terminated

• 1 other identifier: HEPYPRIM
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)

  up to 4 months

Study Arms (2)

National Health Authority (HAS) strategy control

NO INTERVENTION

new strategy experimental

EXPERIMENTAL

Diagnostic Test: PCR test in the stool

Interventions

PCR test in the stool DIAGNOSTIC_TEST

Patients randomized to the "new strategy" arm will receive a prescription for an Hp serology and a stool self-collection kit . Only the result of the PCR test in the stool will be considered for this arm. A positive test will determine Hp infection and the indication for treatment.

new strategy experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 HAS recommendations:
• 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, ATCD of peptic ulcers or precancerous lesions that have not been eradicated, Long-term consumption of NSAIDs, Long-term PPI consumption, or Patient who received Hp eradication treatment without eradication control. or Patient with risk factors for gastric cancer: person related to a patient who has had stomach cancer (parents, brothers / sisters, children); or Patient with a syndrome of predisposition to digestive cancers (Hereditary non-polyposis colorectal carcinoma cancer HNPCC / Lynch syndrome) or Patient who has had a partial gastrectomy or endoscopic treatment of gastric cancerous lesions or Patient with pre-neoplastic gastric lesions (severe atrophy and / or intestinal metaplasia, dysplasia).
• or 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

You may not qualify if:

• Patient not benefiting from a Social Security scheme or not benefiting from it through a third party.
• 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 ).
• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (13)

Vincent HELIS

Frontenay-Rohan-Rohan, France

Location

philippe BRAVIN

Jarnac-Champagne, France

Location

Gwenaelle FARCY

La Mothe-Saint-Héray, France

Location

Marie ROCHEPEAU

La Mothe-Saint-Héray, France

Location

Claude SAPIN

La Roche-Posay, France

Location

Lise BLANCHARD

Mignaloux-Beauvoir, France

Location

ARCHAMBAULT Pierrick

Nueil-les-Aubiers, France

Location

Marc CHABANNE

Pont Labbe Darnoult, France

Location

Elodie POUPIN

Saint-Germain-de-Marencennes, France

Location

Vincent JEDAT

Saint-Jean-d'Angély, France

Location

Christophe BONNET

Tonnay-Charente, France

Location

ANDRIEUX Marine

Vaux-sur-Mer, France

Location

FRECHE Bernard

Vaux-sur-Mer, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: February 3, 2023
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (13)