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

Not Applicable

Recruiting

• Conditions: Asthma in Children; Asthma

• Registration Number: NCT06044051
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-21
• Study Start: 2023-09-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-28
• Primary Completion: 2026-09-26
• Study Completion: 2026-09-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
description of microbiomes from nasopharyngeal samples	at 12 months	analysis of nasopharyngeal samples- NGS sequencing
Description of microbiomes from sputum samples	at 12 months	analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids	at 12 months	analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from sputum samples	at 9 months	analysis of sputum samples- NGS sequencing

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France