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OpenTrials
Completed

NCT Number: NCT03566004

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).

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Key information

Conditions

Helicobacter Pylori

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU DE Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Stool specimen collection

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.

Primary outcomes

  1. Detection of H. pylori by culture or glmM real-time PCR

    Time frame: Day 2

  2. Detection of H. pylori by culture or glmM real-time PCR

    Time frame: Day30

  3. Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.

    Time frame: Day 2

  4. Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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)

Acronym: HEPYSTOOL

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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