Performances of a H. Pylori Stool PCR Test

Not Applicable

Completed

• Conditions: Helicobacter Pylori
• Interventions: Diagnostic Test: Stool specimen collection

• 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

Study Timeline

• Study Start: 2015-12-10
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Status Verified: 2020-03
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

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

Arm && Interventions

Group	Intervention	Description
endoscoped patients	Stool specimen collection	Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen

Primary Outcome Measures

Name	Time	Method
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.	Day 30
Detection of H. pylori by culture or glmM real-time PCR	Day30

Trial Locations

Locations (1)

CHU DE Poitiers; 🇫🇷 Poitiers, France