Performances of a H. Pylori Stool PCR Test (HEPYSTOOL)

July 16, 2020 updated by: Poitiers University Hospital

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • CHU de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: endoscoped patients
Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen
Diagnostic test: Stool specimen collection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of H. pylori by culture or glmM real-time PCR
Time Frame: Day 2
Day 2
Detection of H. pylori by culture or glmM real-time PCR
Time Frame: Day30
Day30
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time Frame: Day 2
Day 2
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time Frame: Day 30
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Christophe BURUCOA, Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2015

Primary Completion (Actual)

June 9, 2020

Study Completion (Actual)

June 9, 2020

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HEPYSTOOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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