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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials