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

Asthma Clinical Trial

— Microbiosthme  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044051
• Other study ID #: 2023/0091/OB
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: September 26, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Rouen
• Contact: David Mallet
• Phone: 02 32 88 82 65
• Email: secretariat.DRC[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 26, 2026
• Est. primary completion date: September 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Blood sample
An additionnal volume of blood will be collected at inclusion and at each follow-up visit
• Expectoration
Expectoration will be collected at inclusion and at each follow-up visit
• Nasopharyngeal swab
A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	description of microbiomes from bronchoalveolar fluids	analysis of bronchoalveolar fluids - NGS sequencing	Inclusion
Primary	description of microbiomes from nasopharyngeal samples	analysis of nasopharyngeal samples- NGS sequencing	Inclusion
Primary	description of microbiomes from sputum samples	analysis of sputum samples- NGS sequencing	Inclusion
Primary	description of microbiomes from bronchoalveolar fluids	analysis of bronchoalveolar fluids- NGS sequencing	at 3 months
Primary	description of microbiomes from nasopharyngeal samples	analysis of nasopharyngeal samples- NGS sequencing	at 3 months
Primary	description of microbiomes from sputum samples	analysis of sputum samples- NGS sequencing	at 3 months
Primary	description of microbiomes from bronchoalveolar fluids	analysis of bronchoalveolar fluids- NGS sequencing	at 6 months
Primary	description of microbiomes from nasopharyngeal samples	analysis of nasopharyngeal samples- NGS sequencing	at 6 months
Primary	description of microbiomes from sputum samples	analysis of sputum samples- NGS sequencing	at 6 months
Primary	description of microbiomes from bronchoalveolar fluids	analysis of bronchoalveolar fluids - NGS sequencing	at 9 months
Primary	description of microbiomes from nasopharyngeal samples	analysis of nasopharyngeal samples- NGS sequencing	at 9 months
Primary	description of microbiomes from sputum samples	analysis of sputum samples- NGS sequencing	at 9 months
Primary	description of microbiomes from bronchoalveolar fluids	analysis of bronchoalveolar fluids- NGS sequencing	at 12 months
Primary	description of microbiomes from nasopharyngeal samples	analysis of nasopharyngeal samples- NGS sequencing	at 12 months
Primary	Description of microbiomes from sputum samples	analysis of sputum samples- NGS sequencing	at 12 months