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French Pediatric Helicobacter Pylori Observatory

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03541876
Acronym
GFHPP
Enrollment
1201
Registered
2018-05-31
Start date
2018-01-09
Completion date
2024-02-29
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

children, treatment, observatory

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.

Interventions

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.

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of H. pylori infectionat inclusionChild with confirmed H. pylori infection by direct diagnostic methods (Histology, Bacterial culture, PCR) on perendoscopic gastric biopsies
Ageat inclusion
Sexat inclusion
Country of birthat inclusion
Clinical symptomsat inclusion, 3 and 6 months
Microbiological diagnosisat inclusion, 3 and 6 months
Endoscopic diagnosisat inclusion, 3 and 6 months
Rates of bacterial resistance profilesat inclusion, at 3 and 6 months
antibiotic therapyat inclusion, 3 and 6 months
Bacterial eradication rates3 and 6 months
Side effects and tolerance of first and second line treatments3 and 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026