TerminatedNot Applicable

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

Stopped: The study was stopped due to recruitment difficulties

France246 participantsStarted 2023-02-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 te…

What they're measuring

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

Timeframe: up to 4 months

Trial details

NCT IDNCT05495854

SponsorPoitiers University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-20