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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,100
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.
Vincent HELIS
Frontenay-Rohan-Rohan, France
RECRUITINGphilippe BRAVIN
Jarnac-Champagne, France
ACTIVE_NOT_RECRUITINGGwenaelle FARCY
La Mothe-Saint-Héray, France
ACTIVE_NOT_RECRUITINGMarie ROCHEPEAU
La Mothe-Saint-Héray, France
RECRUITINGClaude SAPIN
La Roche-Posay, France
RECRUITINGLise BLANCHARD
Mignaloux-Beauvoir, France
RECRUITINGARCHAMBAULT Pierrick
Nueil-les-Aubiers, France
ACTIVE_NOT_RECRUITINGMarc CHABANNE
Pont Labbe Darnoult, France
NOT_YET_RECRUITINGElodie POUPIN
Saint-Germain-de-Marencennes, France
RECRUITINGVincent JEDAT
Saint-Jean-d'Angély, France
RECRUITING...and 3 more locations
Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)
Time frame: up to 4 months
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