French Pediatric Helicobacter Pylori Observatory

Helicobacter Pylori Infection Clinical Trial

— GFHPP  

Official title:

Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03541876
• Other study ID #: RC-P0058
• Status: Active, not recruiting
• Start date: January 9, 2018
• Est. completion date: February 2024

Study information

• Verified date: June 2023
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1201
• Est. completion date: February 2024
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Other:
• Collection of data
The following data will be collected by the physician : sociodemographic profile (age, sex, country of birth of child and parents); clinical manifestations; endoscopic aspects (esophagus, duodenum, stomach); different methods of diagnosis of infection; different primary and secondary bacterial resistance profiles ; different first and second line therapeutic combinations; different first and second line bacterial eradication rates ; different signs of side effects and tolerance of first and second line treatments; different methods of bacterial eradication control.

Locations

Country	Name	City	State
France	Lille Catholic University	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

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