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

NCT05495854 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-04-30

No results posted yet for this 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.

Conditions

  • Helicobacter Pylori Infection

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.

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2025-10-20
Completion
2025-10-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495854 on ClinicalTrials.gov