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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| collection of expectoration, stools and blood | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collection of expectoration, stools and blood | Diagnostic Test | collection of expectoration, stools and blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age | positive or negative | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute amount of P. aeruginosa at different sampling times. | amount (UFC/mL) | 36 months |
| Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Genevieve HERY-ARNAUD, Pr | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Angers | Angers | France | ||||
| Hôpital des Enfants Bordeaux |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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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.
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amount (UFC/mL)
| 36 months |
| Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months. | amount (UFC/mL) | 36 months |
| Level of dysbiosis | 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. | 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. | 36 Months |
| Levels of blood metabolites | 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 | 36 Months |
| Constitutional SNPs | 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 | 36 Months |
| Breastfeeding at each visit | 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. | 36 Months |
| Dietary diversification at each visit | 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. | 36 Months |
| Treatments received at each visit | 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. | 36 Months |
| Bordeaux |
| France |
| CHU Grenoble | Grenoble | France |
| Hôpital Femme-Mère-Enfant Lyon | Lyon | France |
| CHRU Nantes | Nantes | France |
| Hôpital Necker | Paris | France |
| Hôpital Trousseau | Paris | France |
| CHRU Rennes | Rennes | France |
| Centre de Perharidy | Roscoff | France |
| Hôpital Charles Nicolle | Rouen | France |
| CHRU de Tours | Tours | France |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D003672 | Defecation |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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