NCT03947957

Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

Detailed description

This is a multicentric study in 3 phases: * Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR) * Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month * Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old. * Tracheo-bronchial secretions will be collected at the CRCM * Stools samples will be carried out by the parents prior to consultation with the CRCM * A blood collection will be carried out annually in an annual report.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	collection of expectoration, stools and blood	collection of expectoration, stools and blood

Timeline

• Start date: 2020-10-02
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2019-05-13
• Last updated: 2026-02-23

Locations

11 sites across 1 country: France