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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06044051
Acronym
Microbiosthme
Enrollment
100
Registered
2023-09-21
Start date
2023-09-26
Completion date
2026-09-26
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Asthma in Children

Keywords

microbiosme, Asthma in infant

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.

Interventions

OTHERBlood sample

An additionnal volume of blood will be collected at inclusion and at each follow-up visit

OTHERExpectoration

Expectoration will be collected at inclusion and at each follow-up visit

OTHERNasopharyngeal swab

A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
description of microbiomes from bronchoalveolar fluidsInclusionanalysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samplesInclusionanalysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samplesInclusionanalysis of sputum samples- NGS sequencing
Description of microbiomes from sputum samplesat 12 monthsanalysis of sputum samples- NGS sequencing

Countries

France

Contacts

CONTACTDavid Mallet
secretariat.DRC@chu-rouen.fr02 32 88 82 65
PRINCIPAL_INVESTIGATORPETAT Hortense

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026