Performances of a H. Pylori Stool PCR Test

NCT ID: NCT03566004

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-10

Study Completion Date

2020-06-09

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).

Detailed Description

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Conditions

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Helicobacter Pylori

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endoscoped patients

Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen

Group Type OTHER

Stool specimen collection

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe BURUCOA

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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CHU DE Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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HEPYSTOOL

Identifier Type: -

Identifier Source: org_study_id

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