Performances of a H. Pylori Stool PCR Test
Not Applicable
Completed
- Conditions
- Helicobacter Pylori
- Registration Number
- NCT03566004
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
- Age ≥ 18 years
- indication of endoscopy with biopsies for H. pylori infection
- Free subject, without tutorship or curatorship or subordination
- Patients benefiting from a social security scheme or benefiting through a third party
- Consent informed and signed by the patient after clear and fair information about the study
Exclusion Criteria
- Age <18 years
- Contraindications to fibroscopy (suspicion of oesophageal perforation)
- Antibiotic intake less than 4 weeks old
- Diarrheal patients during sampling
- Patients who do not benefit from a social security scheme or who do not benefit from it through a third party
- Persons enjoying enhanced protection, namely minors, pregnant women, breastfeeding, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situation.
- Pregnant or lactating women, women of childbearing potential who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy )
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Detection of H. pylori by culture or glmM real-time PCR Day30 Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies. Day 30
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU DE Poitiers
🇫🇷Poitiers, France
CHU DE Poitiers🇫🇷Poitiers, France