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This observational study investigates microbial biomarkers linked to early colonization by the bacterium Pseudomonas aeruginosa in babies with cystic fibrosis; samples of sputum, stool and blood are collected. It can enroll infants up to 6 months of age with a confirmed classic diagnosis of cystic fibrosis (class I-III CFTR gene mutations) who have not previously had P. aeruginosa colonization. It is a study without an assigned phase and is currently not recruiting but still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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