Cystic Fibrosis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTcollection of expectoration, stools and blood
collection of expectoration, stools and blood
Sponsors
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Infants will be included between the 2nd visit to the CRCM (about 2 months of age) and the 6th month then they will be followed until the age of 36 months. The pace of visits will be based on the usual follow-up rate of CF infants.
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age | 36 months | positive or negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute amount of P. aeruginosa at different sampling times. | 36 months | amount (UFC/mL) |
| Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months. | 36 months | amount (UFC/mL) |
| Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months. | 36 months | amount (UFC/mL) |
| Level of dysbiosis | 36 months | — |
| Pulmonary concentration of inflammatory markers | 36 months | 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. |
| Number, diversity, and quality of antibiotic resistance genes | 36 Months | This objective aims to identify and analyze the antibiotic resistance genes present in pulmonary and intestinal samples from infants with cystic fibrosis. |
| Levels of blood metabolites | 36 Months | This objective aims to measure the levels of blood metabolites in infants with cystic fibrosis throughout follow-up. The purpose is to characterize the metabolic profile associated with disease progression |
| Constitutional SNPs | 36 Months | This objective aims to analyze constitutional single nucleotide polymorphisms (SNPs) in infants with cystic fibrosis. The goal is to explore host genetic variations that may influence susceptibility to early Pseudomonas aeruginosa colonization |
| Breastfeeding at each visit | 36 Months | This objective aims to document breastfeeding status at each follow-up visit in infants with cystic fibrosis. The purpose is to assess the potential impact of breastfeeding on microbiota composition, immune and inflammatory responses, and the risk of early Pseudomonas aeruginosa colonization. |
| Dietary diversification at each visit | 36 Months | This objective aims to record dietary diversification at each follow-up visit in infants with cystic fibrosis. The goal is to evaluate the influence of nutritional diversification on gut and respiratory microbiota composition, inflammatory and metabolic profiles, and the risk of early Pseudomonas aeruginosa colonization. |
| Treatments received at each visit | 36 Months | This objective aims to document all treatments received at each follow-up visit in infants with cystic fibrosis, including antibiotics, CFTR modulators, and other relevant therapies. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGenevieve HERY-ARNAUD, Pr
University Hospital, Brest
Outcome results
None listed