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

Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool

This study is testing a new stool test to see if it can quickly and easily detect Helicobacter Pylori infections and find out which antibiotics will work best for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Poitiers University Hospital (Academic / other)
• Locations: 13 sites (Frontenay-Rohan-Rohan and 12 other locations)
• Trial ID: NCT05495854 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with specific indications for H. Pylori treatment, such as chronic dyspepsia or a history of gastric cancer.

Not a fit: Patients who do not have indications for H. Pylori treatment or are under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and less invasive treatment options for patients with Helicobacter Pylori infections.

How similar studies have performed: Previous studies have shown promising results with similar non-invasive testing approaches, indicating potential for success in this trial.

Eligibility criteria

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 this trial is running

Frontenay-Rohan-Rohan and 12 other locations

• Vincent HELIS — Frontenay-Rohan-Rohan, France (Recruiting)
• philippe BRAVIN — Jarnac-champagne, France (Active_not_recruiting)
• Gwenaelle FARCY — La Mothe-Saint-Héray, France (Active_not_recruiting)
• Marie ROCHEPEAU — La Mothe-Saint-Héray, France (Recruiting)
• Claude SAPIN — La Roche-Posay, France (Recruiting)
• Lise BLANCHARD — Mignaloux Beauvoir, France (Recruiting)
• ARCHAMBAULT Pierrick — Nueil les aubiers, France (Active_not_recruiting)
• Marc CHABANNE — Pont Labbe Darnoult, France (Not_yet_recruiting)
• Elodie POUPIN — Saint-Germain-de-Marencennes, France (Recruiting)
• Vincent JEDAT — Saint-Jean-d'Angély, France (Recruiting)
• Christophe BONNET — Tonnay-Charente, France (Recruiting)
• ANDRIEUX Marine — Vaux-sur-Mer, France (Recruiting)
• FRECHE Bernard — Vaux-sur-Mer, France (Recruiting)

Study contacts

• Study coordinator: BERNARD FRECHE, Dr

Conditions Helicobacter Pylori Infection