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

P

Poitiers University Hospital

Status

Completed

Conditions

Helicobacter Pylori

Treatments

Diagnostic Test: Stool specimen collection

Study type

Interventional

Funder types

Other

Identifiers

NCT03566004
HEPYSTOOL

Details and patient eligibility

About

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).

Enrollment

1,200 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No 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 )

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,200 participants in 1 patient group

endoscoped patients
Other group
Description:
Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen
Treatment:
Diagnostic Test: Stool specimen collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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