Performances of a H. Pylori Stool PCR Test

Helicobacter Pylori Clinical Trial

— HEPYSTOOL  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566004
• Other study ID #: HEPYSTOOL
• Status: Completed
• Phase: N/A
• Start date: December 10, 2015
• Est. completion date: June 9, 2020

Study information

• Verified date: March 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

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.

Locations

Country	Name	City	State
France	CHU DE Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of H. pylori by culture or glmM real-time PCR		Day 2
Primary	Detection of H. pylori by culture or glmM real-time PCR		Day30
Primary	Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.		Day 2
Primary	Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.		Day 30