the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.

A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03134495

Acronym

UTOPIE

Enrollment

290286

Registered

2017-05-01

Start date

2015-03-31

Completion date

2017-04-30

Last updated

2017-05-01

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

Conditions

Community Infections

Brief summary

Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia. Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.

Interventions

OTHERall children with at least one prescription of PPI

all children with at least one prescription of PPI

OTHERall children with no prescription of PPI

all children with no prescription of PPI

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 11 Years

Healthy volunteers

Inclusion criteria

* Children aged 11 years or below with at least 2 consultations during the follow up

Exclusion criteria

* chronic pulmonary or cardiac * muscoviscidosis * immunodeficiency * H. pylori infection * Diabetes * Denutrition * known digestive upper tract malformation

Design outcomes

Primary

Measure	Time frame	Description
Number of overall infections	4 years	Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account

Secondary

Measure	Time frame	Description
Number of specific infections	4 years	Comparison of number of infections between PPI exposed and non-exposed

Countries

France

Outcome results

None listed

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