An interventional study of PCR test in the stool and Hp serology and gastroscopy in Helicobacter Pylori Infection, sponsored by Poitiers University Hospital. Terminated at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Diagnostic
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.
Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with an indication for research and treatment of an Hp infection according to National Health Authority (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; history of peptic ulcers or precancerous lesions that have not been eradicated; Long-term consumption of NSAIDs; Long-term PPI consumption.
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
Exclusion Criteria:
Exclusion criteria related to non-compliance with ambivalence:
Patients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication.
Diagnostic Test: PCR test in the stool · Diagnostic Test: Hp serology and gastroscopy
Patients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication.
Diagnostic Test: PCR test in the stool · Diagnostic Test: Hp serology and gastroscopy
Patients receive a prescription for a stool self-collection kit.
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.
Proportion of patients with a negative urea breath test (proof of Hp eradication)
Urea breath test is carried out 6 weeks after the end of treatment
Time frame: up to 4 months after inclusion
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Plan to share: No
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Poitiers University Hospital