French Pediatric Helicobacter Pylori Observatory

NCT ID: NCT03541876

Last Updated: 2023-06-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-09

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Helicobacter Pylori Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children with H. pylori infection

Collection of data

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Kalach, PR

Role: PRINCIPAL_INVESTIGATOR

Lille Catholic University

Locations

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Lille Catholic University

Lille, , France

Site Status

Countries

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France

Other Identifiers

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RC-P0058

Identifier Type: -

Identifier Source: org_study_id

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