HEPYSTOOL: Performances of a H. Pylori Stool PCR Test

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03566004

Collaborator

(none)

1,200

Enrollment

Location

Arm

Actual Duration (Months)

22.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Diagnostic Test: Stool specimen collection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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)

Actual Study Start Date :

Dec 10, 2015

Actual Primary Completion Date :

Jun 9, 2020

Actual Study Completion Date :

Jun 9, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 )

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU DE Poitiers	Poitiers		France

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator: Christophe BURUCOA, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT03566004

Other Study ID Numbers:

HEPYSTOOL

First Posted:

Jun 21, 2018

Last Update Posted:

Jul 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 17, 2020