Helicobacter PyloriHEPYSTOOLNCT03566004
Performances of a H. Pylori Stool PCR Test
A study testing Stool specimen collection in people with Helicobacter Pylori, run by Poitiers University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Stool specimen collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2015to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Helicobacter Pylori
- Being tested
- Stool specimen collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool specimen collectionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| endoscoped patients | Other | Patients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen Receives: Diagnostic Test: Stool specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of H. pylori by culture or glmM real-time PCR
Measured: Day 2
Detection of H. pylori by culture or glmM real-time PCR
Measured: Day30
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Measured: Day 2
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start10 Dec 2015
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe BURUCOA, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566004
- Sponsor's protocol ID
- HEPYSTOOL
- Acronym
- HEPYSTOOL
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03566004
- Acronym / sponsor ID
- HEPYSTOOL / HEPYSTOOL
- Conditions
- Helicobacter Pylori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscoped patients | Other | Diagnostic Test: Stool specimen collectionPatients addressed for endoscopy with indication of biopsies for H. pylori detection will be enroled to provide stool specimen |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool specimen collectionThe 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. | Diagnostic test | endoscoped patients |
Primary outcome
Detection of H. pylori by culture or glmM real-time PCR
Time frame: Day 2
Detection of H. pylori by culture or glmM real-time PCR
Time frame: Day30
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time frame: Day 2
Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe BURUCOA principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool specimen collection in people with Helicobacter Pylori, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of H. pylori by culture or glmM real-time PCR (time frame: Day 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.