French Pediatric Helicobacter Pylori Observatory

Active, not recruiting

• Conditions: Helicobacter Pylori Infection

• Registration Number: NCT03541876
• Lead Sponsor: Lille Catholic University

Brief Summary

Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.

No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-31
• Primary Completion: 2022-02-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1201

Inclusion Criteria

• Child with confirmed H. pylori infection by direct diagnostic methods after periendoscopic gastric biopsies
• Age < 18
• No opposition of at least one of the 2 parents to the use of health data for research purposes

Exclusion Criteria

• Child with confirmed H. pylori infection by indirect diagnostic methods

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sex	at inclusion
Clinical symptoms	at inclusion, 3 and 6 months
Microbiological diagnosis	at inclusion, 3 and 6 months
Side effects and tolerance of first and second line treatments	3 and 6 months
Diagnosis of H. pylori infection	at inclusion	Child with confirmed H. pylori infection by direct diagnostic methods (Histology, Bacterial culture, PCR) on perendoscopic gastric biopsies
Country of birth	at inclusion
Age	at inclusion
Rates of bacterial resistance profiles	at inclusion, at 3 and 6 months
antibiotic therapy	at inclusion, 3 and 6 months
Endoscopic diagnosis	at inclusion, 3 and 6 months
Bacterial eradication rates	3 and 6 months

Trial Locations

Locations (1)

Lille Catholic University; 🇫🇷 Lille, France