Performances of a H. Pylori Stool PCR Test

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03566004

Acronym

HEPYSTOOL

Enrollment

1200

Registered

2018-06-21

Start date

2015-12-10

Completion date

2020-06-09

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori

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).

Interventions

DIAGNOSTIC_TESTStool 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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 )

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026