- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566004
Performances of a H. Pylori Stool PCR Test (HEPYSTOOL)
July 16, 2020 updated by: Poitiers University Hospital
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Poitiers, France
- CHU De Poitiers
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: endoscoped patients
Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection of H. pylori by culture or glmM real-time PCR
Time Frame: Day 2
|
Day 2
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Detection of H. pylori by culture or glmM real-time PCR
Time Frame: Day30
|
Day30
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Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time Frame: Day 2
|
Day 2
|
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time Frame: Day 30
|
Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christophe BURUCOA, Poitiers university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2015
Primary Completion (Actual)
June 9, 2020
Study Completion (Actual)
June 9, 2020
Study Registration Dates
First Submitted
February 27, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 21, 2018
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- HEPYSTOOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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