Non-invasive detection and treatment of Helicobacter Pylori infections using stool PCR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to implement a new non-invasive PCR test on stool samples to detect Helicobacter Pylori infections and determine antibiotic sensitivity. The approach seeks to improve treatment strategies by moving away from invasive endoscopy and culture methods, which are currently underutilized despite recommendations. By utilizing this innovative testing method, the study hopes to provide more effective, cost-efficient, and better-tolerated treatment options for patients suffering from H. Pylori infections. The trial will include patients who meet specific criteria related to their health conditions and history.

Why it matters

Who can join: the full rules

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

Where it's running

• Vincent HELIS
  Frontenay-Rohan-Rohan, France Recruiting
• Marie ROCHEPEAU
  La Mothe-Saint-Héray, France Recruiting
• Claude SAPIN
  La Roche-Posay, France Recruiting
• Lise BLANCHARD
  Mignaloux Beauvoir, France Recruiting
• Elodie POUPIN
  Saint-Germain-de-Marencennes, France Recruiting
• Vincent JEDAT
  Saint-Jean-d'Angély, France Recruiting

Study contacts

• Study coordinator: BERNARD FRECHE, Dr
• Email: bernard.freche@univ-poitiers.fr
• Phone: +33.6.83.01.19.10

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection

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• Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children

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• Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication

  This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.

  Recruiting Phase 2/3 First People's Hospital of Hangzhou · Hangzhou, Zhejiang · NCT07242456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.