French Pediatric Helicobacter Pylori Observatory (GFHPP)

June 21, 2023 updated by: Lille Catholic University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Lille Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with confirmed diagnosis of H. pylori infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with H. pylori infection
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Nicolas Kalach, PR, Lille Catholic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2018

Primary Completion (Actual)

February 1, 2022

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC-P0058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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