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New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PCR test in the stool
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 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 not benefiting from a Social Security scheme or not benefiting from it through a third party.
  • 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

Sites / Locations

  • Vincent HELISRecruiting
  • philippe BRAVIN
  • Gwenaelle FARCY
  • Marie ROCHEPEAURecruiting
  • Claude SAPINRecruiting
  • Lise BLANCHARDRecruiting
  • ARCHAMBAULT Pierrick
  • Marc CHABANNE
  • Elodie POUPINRecruiting
  • Vincent JEDATRecruiting
  • Christophe BONNETRecruiting
  • ANDRIEUX MarineRecruiting
  • FRECHE BernardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

National Health Authority (HAS) strategy control

new strategy experimental

Arm Description

Outcomes

Primary Outcome Measures

Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
September 13, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05495854
Brief Title
New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
February 3, 2024 (Anticipated)
Study Completion Date
February 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
National Health Authority (HAS) strategy control
Arm Type
No Intervention
Arm Title
new strategy experimental
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PCR test in the stool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 not benefiting from a Social Security scheme or not benefiting from it through a third party. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BERNARD FRECHE, Dr
Phone
+33.6.83.01.19.10
Email
bernard.freche@univ-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Karine ESTEVE-GARNIER
Email
karine.garnier@chu-poitiers.fr
Facility Information:
Facility Name
Vincent HELIS
City
Frontenay-Rohan-Rohan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent HELIS
Facility Name
philippe BRAVIN
City
Jarnac-champagne
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Gwenaelle FARCY
City
La Mothe-Saint-Héray
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Marie ROCHEPEAU
City
La Mothe-Saint-Héray
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie ROCHEPEAU
Facility Name
Claude SAPIN
City
La Roche-Posay
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude SAPIN
Facility Name
Lise BLANCHARD
City
Mignaloux Beauvoir
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise BLANCHARD
Facility Name
ARCHAMBAULT Pierrick
City
Nueil les aubiers
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Marc CHABANNE
City
Pont Labbe Darnoult
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc CHABANNE
Facility Name
Elodie POUPIN
City
Saint-Germain-de-Marencennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie POUPIN
Facility Name
Vincent JEDAT
City
Saint-Jean-d'Angély
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
vincent JEDAT
Facility Name
Christophe BONNET
City
Tonnay-Charente
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BONNET
Facility Name
ANDRIEUX Marine
City
Vaux-sur-Mer
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine ANDRIEUX, Dr
Facility Name
FRECHE Bernard
City
Vaux-sur-Mer
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard FRECHE, Dr

12. IPD Sharing Statement

Learn more about this trial

New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool

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