Clinical trial NCT06044051: Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
Official title: Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Asthma
Keywords: microbiosme
Asthma in infant
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: description of microbiomes from bronchoalveolar fluids
timeFrame: Inclusion
measure: description of microbiomes from nasopharyngeal samples
timeFrame: Inclusion
measure: description of microbiomes from sputum samples
timeFrame: Inclusion
measure: description of microbiomes from bronchoalveolar fluids
timeFrame: at 3 months
measure: description of microbiomes from nasopharyngeal samples
timeFrame: at 3 months
measure: description of microbiomes from sputum samples
timeFrame: at 3 months
measure: description of microbiomes from bronchoalveolar fluids
timeFrame: at 6 months
measure: description of microbiomes from nasopharyngeal samples
timeFrame: at 6 months
measure: description of microbiomes from sputum samples
timeFrame: at 6 months
measure: description of microbiomes from bronchoalveolar fluids
timeFrame: at 9 months
measure: description of microbiomes from nasopharyngeal samples
timeFrame: at 9 months
measure: description of microbiomes from sputum samples
timeFrame: at 9 months
measure: description of microbiomes from bronchoalveolar fluids
timeFrame: at 12 months
measure: description of microbiomes from nasopharyngeal samples
timeFrame: at 12 months
measure: Description of microbiomes from sputum samples
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: PETAT Hortense
role: PRINCIPAL_INVESTIGATOR
References: