Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma

Study Overview
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Brief Summary
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Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. Exploring and understanding these data is to improve patient care and discover new therapeutic targets. The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.

Official Title
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Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons

Conditions
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Asthma in Children, Asthma

Intervention / Treatment
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* Other: Blood sample
* Other: Expectoration
* Other: Nasopharyngeal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants less than 24 months old Follow-up by a pneumo-pediatrician for severe asthma in infants Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009) Parent informed of the research and having signed consent Exclusion Criteria: Prematurity <32 WA Congenital heart disease with significant left to right shunt Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans) Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization) Refusal of bronchial fibroscopy

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>All patients included will be followed for 1 year, every 3 months | Other: Blood sample<br>* An additionnal volume of blood will be collected at inclusion and at each follow-up visit<br>Other: Expectoration<br>* Expectoration will be collected at inclusion and at each follow-up visit<br>Other: Nasopharyngeal swab<br>* A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of microbiomes from bronchoalveolar fluids | analysis of bronchoalveolar fluids - NGS sequencing | Inclusion | 
| description of microbiomes from nasopharyngeal samples | analysis of nasopharyngeal samples- NGS sequencing | Inclusion | 
| description of microbiomes from sputum samples | analysis of sputum samples- NGS sequencing | Inclusion | 
| description of microbiomes from bronchoalveolar fluids | analysis of bronchoalveolar fluids- NGS sequencing | at 3 months | 
| description of microbiomes from nasopharyngeal samples | analysis of nasopharyngeal samples- NGS sequencing | at 3 months | 
| description of microbiomes from sputum samples | analysis of sputum samples- NGS sequencing | at 3 months | 
| description of microbiomes from bronchoalveolar fluids | analysis of bronchoalveolar fluids- NGS sequencing | at 6 months | 
| description of microbiomes from nasopharyngeal samples | analysis of nasopharyngeal samples- NGS sequencing | at 6 months | 
| description of microbiomes from sputum samples | analysis of sputum samples- NGS sequencing | at 6 months | 
| description of microbiomes from bronchoalveolar fluids | analysis of bronchoalveolar fluids - NGS sequencing | at 9 months | 
| description of microbiomes from nasopharyngeal samples | analysis of nasopharyngeal samples- NGS sequencing | at 9 months | 
| description of microbiomes from sputum samples | analysis of sputum samples- NGS sequencing | at 9 months | 
| description of microbiomes from bronchoalveolar fluids | analysis of bronchoalveolar fluids- NGS sequencing | at 12 months | 
| description of microbiomes from nasopharyngeal samples | analysis of nasopharyngeal samples- NGS sequencing | at 12 months | 
| Description of microbiomes from sputum samples | analysis of sputum samples- NGS sequencing | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiosme, Asthma in infant