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TERMINATED
NCT05495854
NA

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

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2023-02-03

Completion Date

2025-10-20

Last Updated

2026-04-30

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

PCR test in the stool

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.

Locations (13)

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