Performances of a H. Pylori Stool PCR Test
HEPYSTOOL
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)
1 other identifier
interventional
1,200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2020
CompletedJuly 17, 2020
March 1, 2020
4.5 years
February 27, 2018
July 16, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Detection of H. pylori by culture or glmM real-time PCR
Day 2
Detection of H. pylori by culture or glmM real-time PCR
Day30
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Day 2
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Day 30
Study Arms (1)
endoscoped patients
OTHERPatients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU DE Poitiers
Poitiers, France
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe BURUCOA
Poitiers University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
June 21, 2018
Study Start
December 10, 2015
Primary Completion
June 9, 2020
Study Completion
June 9, 2020
Last Updated
July 17, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share