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

N/AActive Not RecruitingNCT03947957

University Hospital, Brest70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

collection of expectoration, stools and bloodDIAGNOSTIC_TEST

collection of expectoration, stools and blood

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 6 Months

Medical Language ↔ Plain English

Inclusion criteria: * Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III) -Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)--- * Affiliation to the social security system * Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder Exclusion criteria: * Severe acute illness (other than cystic fibrosis) ongoing, or requiring surgery * Children unable to undergo the tests required by the protocol * Children whose parent(s) is/are minors * Children whose legal guardians do not have sufficient command of the French language * Children under exclusive parenteral nutrition * Refusal to participate in the study

Locations (11)

CHRU Angers

Angers, France

Hôpital des Enfants Bordeaux

Bordeaux, France

CHU Grenoble

Grenoble, France

Hôpital Femme-Mère-Enfant Lyon

Lyon, France

Outcomes

Primary Outcomes

Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age

positive or negative

Time frame: 36 months

Secondary Outcomes

Absolute amount of P. aeruginosa at different sampling times.

amount (UFC/mL)

Time frame: 36 months

Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.

amount (UFC/mL)

Time frame: 36 months

Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.

amount (UFC/mL)

Time frame: 36 months

Level of dysbiosis

Time frame: 36 months

Pulmonary concentration of inflammatory markers

This objective aims to measure the concentration of inflammatory markers in pulmonary secretions collected from infants with cystic fibrosis during follow-up. The goal is to characterize the intensity and dynamics of the local inflammatory response and to relate these data to the evolution of the respiratory microbiota.

Time frame: 36 months

Number, diversity, and quality of antibiotic resistance genes

This objective aims to identify and analyze the antibiotic resistance genes present in pulmonary and intestinal samples from infants with cystic fibrosis.

Time frame: 36 Months

Levels of blood metabolites

Data from ClinicalTrials.gov

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