Helicobacter Pylori Infection
Conditions
Keywords
non-invasive diagnostic test
Brief 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.
Interventions
DIAGNOSTIC_TESTPCR test in the stool
Patients receive a prescription for a stool self-collection kit.
DIAGNOSTIC_TESTHp serology and gastroscopy
Patients receive a prescription for an Hp serology. A positive serological test will lead to a gastroscopy with biopsies for histology/pathological and bacteriological analyses.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 National Health Authority (HAS) recommendations: 1. 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; history of peptic ulcers or precancerous lesions that have not been eradicated; Long-term consumption of NSAIDs; Long-term PPI consumption. or 2. Patient who received Hp eradication treatment without eradication control. or 3. Patient with risk factors for gastric cancer: person related to a patient who has had stomach cancer (parents, brothers / sisters, children). or 4. Patient with a syndrome of predisposition to digestive cancers (Hereditary non-polyposis colorectal carcinoma cancer HNPCC / Lynch syndrome). or 5. Patient who has had a partial gastrectomy or endoscopic treatment of gastric cancerous lesions. or 6. Patient with pre-neoplastic gastric lesions (severe atrophy and / or intestinal metaplasia, dysplasia). or 7. 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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a negative urea breath test (proof of Hp eradication) | up to 4 months after inclusion | Urea breath test is carried out 6 weeks after the end of treatment |
Countries
France
Outcome results
None listed