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CompletedNCT03566004HEPYSTOOLUpdated Jul 17, 2020

Performances of a H. Pylori Stool PCR Test

An interventional study of Stool specimen collection in Helicobacter Pylori, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Dec 2015, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Helicobacter Pylori
03

In context

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 )
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,200 participants (actual)

Study arms

  • Other
    endoscoped patients

    Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen

    Diagnostic Test: Stool specimen collection

Interventions

  • Diagnostic testStool 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.

06

What researchers measure

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

07

Study locations

1 site
  • CHU DE Poitiers
    Poitiers, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03566004
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Dec 10, 2015
Primary completion
Jun 9, 2020
Completion
Jun 9, 2020
Last update
Jul 17, 2020

Study contacts

Christophe BURUCOA
principal investigator · Poitiers University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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