NCT05495854

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-02-03
• Primary completion: 2024-02-03
• Completion: 2024-02-03
• First posted: 2022-08-10
• Last updated: 2023-09-14

Locations

13 sites across 1 country: France