Performances of a H. Pylori Stool PCR Test

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Helicobacter Pylori

Intervention / Treatment
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* Diagnostic Test: Stool specimen collection


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: endoscoped patients<br>Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen | Diagnostic Test: Stool specimen collection<br>* The stool specimen collection was performed at the hospital or at home using a disposable device to be placed on the toilet seat and an E-nat Tube sent by postal to the lab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of H. pylori by culture or glmM real-time PCR |  | Day 2 | 
| 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 2 | 
| Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies. |  | Day 30 |