New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool
NCT ID: NCT05495854
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1100 participants
INTERVENTIONAL
2023-02-03
2024-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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National Health Authority (HAS) strategy control
No interventions assigned to this group
new strategy experimental
PCR test in the stool
Patients randomized to the "new strategy" arm will receive a prescription for an Hp serology and a stool self-collection kit . Only the result of the PCR test in the stool will be considered for this arm. A positive test will determine Hp infection and the indication for treatment.
Interventions
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PCR test in the stool
Patients randomized to the "new strategy" arm will receive a prescription for an Hp serology and a stool self-collection kit . Only the result of the PCR test in the stool will be considered for this arm. A positive test will determine Hp infection and the indication for treatment.
Eligibility Criteria
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Inclusion Criteria
* 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 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, ATCD of peptic ulcers or precancerous lesions that have not been eradicated, Long-term consumption of NSAIDs, Long-term PPI consumption, 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Vincent HELIS
Frontenay-Rohan-Rohan, , France
philippe BRAVIN
Jarnac-Champagne, , France
Gwenaelle FARCY
La Mothe-Saint-Héray, , France
Marie ROCHEPEAU
La Mothe-Saint-Héray, , France
Claude SAPIN
La Roche-Posay, , France
Lise BLANCHARD
Mignaloux-Beauvoir, , France
ARCHAMBAULT Pierrick
Nueil-les-Aubiers, , France
Marc CHABANNE
Pont Labbe Darnoult, , France
Elodie POUPIN
Saint-Germain-de-Marencennes, , France
Vincent JEDAT
Saint-Jean-d'Angély, , France
Christophe BONNET
Tonnay-Charente, , France
ANDRIEUX Marine
Vaux-sur-Mer, , France
FRECHE Bernard
Vaux-sur-Mer, , France
Countries
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Central Contacts
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Facility Contacts
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Vincent HELIS
Role: primary
Marie ROCHEPEAU
Role: primary
Claude SAPIN
Role: primary
Lise BLANCHARD
Role: primary
Marc CHABANNE
Role: primary
Elodie POUPIN
Role: primary
vincent JEDAT
Role: primary
Christophe BONNET
Role: primary
Marine ANDRIEUX, Dr
Role: primary
Bernard FRECHE, Dr
Role: primary
Other Identifiers
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HEPYPRIM
Identifier Type: -
Identifier Source: org_study_id
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