Overview
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.
Eligibility
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 test (biopsy not addressed in bacteriology) and for whom we want to
undergo a guided treatment
Exclusion Criteria:
- Patient not benefiting from a Social Security scheme or not benefiting from it through
a third party.
- Patient benefiting from enhanced protection, namely minors, pregnant or breastfeeding
women, persons deprived of their liberty by a judicial or administrative decision,
persons staying in a health or social establishment, adults under legal protection and
finally patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who do not have effective
contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable,
intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy ).
Exclusion criteria related to non-compliance with ambivalence:
- Allergy to amoxicillin (suspected or documented)
- Contraindication to eso-gastro-duodenal fibroscopy and biopsies
- Use of antibiotic within 15 days before enrolment
- Patient with an indication to perform an endoscopy of the upper digestive system in
Emergency according to the criteria of "the European Panel on the Appropriateness of
Gastrointestinal Endoscopy (EPAGE II)": upper gastrointestinal hemorrhage, acute
deglobulization without digestive hemorrhage externalized, ingestion of caustics,
acute dysphagia or ingestion of foreign bodies
- Participating another interventional trial