Actively Recruiting

Phase Not Applicable
Age: 0 - 24Months
All Genders
ID06044051

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

Led by University Hospital, Rouen · Updated on 2026-02-17

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 0 - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Parent informed of the research and having signed consent
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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)

Trial Site Locations

Total: 1 location

1

Rouen University Hospital

Rouen, France

Actively Recruiting

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Research Team

D

David Mallet

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.

Hortense Petat, Chervin Hassel, Alice Michel...

https://pubmed.ncbi.nlm.nih.gov/40670979