Study of Upper and Lower Airway Microbiomes in Infants with Severe Asthma and Their Evolution During Treatment
Led by University Hospital, Rouen · Updated on 2026-02-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying severe asthma in infants under 24 months old to understand how imbalances in the different microbiomes of the respiratory tract and the immune system may contribute to the disease and how these factors change with treatment. The goal is to improve care and find new treatment targets, such as exploring azithromycin as an immune system modulator, though current results on this are mixed.
All infants in the study will be followed for one year with visits every three months. During these visits, samples including blood, expectoration, and nasopharyngeal swabs will be collected to analyze the microbiomes from different parts of the respiratory tract at inclusion and at 3, 6, 9, and 12 months.
Participants will undergo bronchial fibroscopy as part of their clinical evaluation. Researchers will describe the microbiomes from bronchoalveolar fluids, nasopharyngeal samples, and sputum collected at each visit. The study aims to monitor changes in these microbiomes over time alongside clinical assessments. Parents will provide informed consent, and the total participation lasts one year with regular follow-ups.
CONDITIONS
Brief Title
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
Research Team
D
David Mallet
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Follow-up by a pneumo-pediatrician for severe asthma in infants
Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy
Parent informed of the research and having signed consent
You will not qualify if you...
Prematurity less than 32 weeks of gestation
Congenital heart disease with significant left to right shunt
Chronic respiratory disease other than infant asthma (such as cystic fibrosis, bronchiolitis obliterans)
Antibiotic therapy in progress or administered in the seven days before inclusion
Refusal of bronchial fibroscopy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Monitoring
Duration - 1 year
Participants are followed to collect respiratory and blood samples every 3 months for 1 year to study the dynamics of the upper and lower airway microbiomes associated with severe infant asthma.
Quarterly visits every 3 months for a total of 4 visits (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Microbiosthma: a prospective study following respiratory microbiota in young children with severe preschool wheezing to better understand their respiratory future.