Helicobacter Pylori InfectionHEPYPRIMNCT05495854
New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool
A study testing PCR test in the stool and Hp serology and gastroscopy in people with Helicobacter Pylori Infection, run by Poitiers University Hospital at 13 sites in France.
Trial summary
In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PCR test in the stool and Hp serology and gastroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 13 sitesFrance
- Study dates
- 3 Feb 2023to 20 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person over 18 years old
- Patient affiliated or beneficiary of a social security scheme.
- Informed consent signed by the patient after clear and fair information about the study
- Patient registered on the list of patients who signed a doctor's statement with the investigating doctor.
- Patient with an indication for research and treatment of an Hp infection according to National Health Authority (HAS) recommendations:
- Suffering from (at least one) : Chronic dyspepsia; Iron deficiency anemia without a found cause or resistant to iron supplementation; Vitamin B12 deficiency without a found cause; familial gastric cancer DCDS; Immunological thrombocytopenic purpura in adulthood; history of peptic ulcers or precancerous lesions that have not been eradicated; Long-term consumption of NSAIDs; Long-term PPI consumption.
Show all 17Show fewer
- or
- Patient who received Hp eradication treatment without eradication control. or
- Patient with risk factors for gastric cancer: person related to a patient who has had stomach cancer (parents, brothers / sisters, children).
- or
- Patient with a syndrome of predisposition to digestive cancers (Hereditary non-polyposis colorectal carcinoma cancer HNPCC / Lynch syndrome).
- or
- Patient who has had a partial gastrectomy or endoscopic treatment of gastric cancerous lesions.
- or
- Patient with pre-neoplastic gastric lesions (severe atrophy and / or intestinal metaplasia, dysplasia).
- or
- Patient who has already undergone an endoscopy with detection of Hp but without antibiotic sensitivity test (biopsy not addressed in bacteriology) and for whom we want to undergo a guided treatment.
Who cannot join
- Patient benefiting from enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
- Exclusion criteria related to non-compliance with ambivalence:
- Allergy to amoxicillin (suspected or documented).
- Contraindication to eso-gastro-duodenal fibroscopy and biopsies.
- Use of antibiotic within 15 days before enrolment.
- Patient with an indication to perform an endoscopy of the upper digestive system in Emergency according to the criteria of "the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE II)": upper gastrointestinal hemorrhage; acute deglobulization without digestive hemorrhage externalized; ingestion of caustics; acute dysphagia or ingestion of foreign bodies.
- Participating another interventional trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Vincent HELIS
Frontenay-Rohan-Rohan
philippe BRAVIN
Jarnac-Champagne
Gwenaelle FARCY
La Mothe-Saint-Héray
Marie ROCHEPEAU
La Mothe-Saint-Héray
Claude SAPIN
La Roche-Posay
Lise BLANCHARD
Mignaloux-Beauvoir
ARCHAMBAULT Pierrick
Nueil-les-Aubiers
Marc CHABANNE
Pont Labbe Darnoult
Elodie POUPIN
Saint-Germain-de-Marencennes
Vincent JEDAT
Saint-Jean-d'Angély
Christophe BONNET
Tonnay-Charente
ANDRIEUX Marine
Vaux-sur-Mer
FRECHE Bernard
Vaux-sur-Mer
About this study
Official title: Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool
In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PCR test in the stool, Hp serology and gastroscopy
- Keywords
- non-invasive diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR test in the stoolDiagnostic test
Patients receive a prescription for a stool self-collection kit.
Hp serology and gastroscopyDiagnostic test
Patients receive a prescription for an Hp serology. A positive serological test will lead to a gastroscopy with biopsies for histology/pathological and bacteriological analyses.
| Study group | Role | What they receive |
|---|---|---|
| National Health Authority (HAS) strategy control | Active comparator | Patients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication. Receives: Diagnostic Test: PCR test in the stool; Diagnostic Test: Hp serology and gastroscopy |
| new strategy experimental | Experimental | Patients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication. Receives: Diagnostic Test: PCR test in the stool; Diagnostic Test: Hp serology and gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a negative urea breath test (proof of Hp eradication)
Urea breath test is carried out 6 weeks after the end of treatment
Measured: up to 4 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start3 Feb 2023
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Why it stopped: The study was stopped due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495854
- Sponsor's protocol ID
- HEPYPRIM
- Acronym
- HEPYPRIM
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pichon M, Freche B, Burucoa C. New Strategy for the Detection and Treatment of Helicobacter pylori Infections in Primary Care Guided by a Non-Invasive PCR in Stool: Protocol of the French HepyPrim Study. J Clin Med. 2022 Feb 22;11(5):1151. doi: 10.3390/jcm11051151.
PubMed 35268242
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool
- ClinicalTrials.gov ID
- NCT05495854
- Acronym / sponsor ID
- HEPYPRIM / HEPYPRIM
- Conditions
- Helicobacter Pylori Infection
- Keywords
- non-invasive diagnostic test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to recruitment difficulties
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 10 Aug 2022 (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.
In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| National Health Authority (HAS) strategy control | Active comparator | Diagnostic Test: PCR test in the stool, Diagnostic Test: Hp serology and gastroscopyPatients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication. |
| new strategy experimental | Experimental | Diagnostic Test: PCR test in the stool, Diagnostic Test: Hp serology and gastroscopyPatients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Person over 18 years old
- Patient affiliated or beneficiary of a social security scheme.
- Informed consent signed by the patient after clear and fair information about the study
- Patient registered on the list of patients who signed a doctor's statement with the investigating doctor.
- Patient with an indication for research and treatment of an Hp infection according to National Health Authority (HAS) recommendations:
Key exclusion criteria (8 listed)
- Patient benefiting from enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
- Allergy to amoxicillin (suspected or documented).
- Contraindication to eso-gastro-duodenal fibroscopy and biopsies.
- Use of antibiotic within 15 days before enrolment.
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 |
|---|---|---|
| PCR test in the stoolPatients receive a prescription for a stool self-collection kit. | Diagnostic test | National Health Authority (HAS) strategy control, new strategy experimental |
| Hp serology and gastroscopyPatients receive a prescription for an Hp serology. A positive serological test will lead to a gastroscopy with biopsies for histology/pathological and bacteriological analyses. | Diagnostic test | National Health Authority (HAS) strategy control, new strategy experimental |
Primary outcome
Proportion of patients with a negative urea breath test (proof of Hp eradication)
Time frame: up to 4 months after inclusion
Urea breath test is carried out 6 weeks after the end of treatment
Results and safety
The study was stopped early (reason given: The study was stopped due to recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 35268242Pichon M, Freche B, Burucoa C. New Strategy for the Detection and Treatment of Helicobacter pylori Infections in Primary Care Guided by a Non-Invasive PCR in Stool: Protocol of the French HepyPrim Study. J Clin Med. 2022 Feb 22;11(5):1151. doi: 10.3390/jcm11051151.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR test in the stool and Hp serology and gastroscopy in people with Helicobacter Pylori Infection, run by Poitiers University Hospital at 13 sites 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 17 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 was stopped early (reason given: The study was stopped due to recruitment difficulties). Results are not available in the source record.
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?
Proportion of patients with a negative urea breath test (proof of Hp eradication) (time frame: up to 4 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495854, which also lists 1 linked publication.
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 1 Sep 2026.