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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06044051

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this project is to establish the nature of potential dysbiosis, the interrelation of the different microbiomes of the respiratory tract, and the potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. The aim of exploring and understanding these data is to ultimately improve patient care and discover new therapeutic targets.

Indeed, modification of the microbiota was a therapeutic target even before it was discovered, and its immunomodulatory properties reinforce this position.

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children Asthma	Other: Blood sample Other: Expectoration Other: Nasopharyngeal swab	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 26, 2023

Anticipated Primary Completion Date :

Sep 26, 2026

Anticipated Study Completion Date :

Sep 26, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: All patients All patients included will be followed for 1 year, every 3 months	Other: Blood sample An additionnal volume of blood will be collected at inclusion and at each follow-up visit Other: Expectoration Expectoration will be collected at inclusion and at each follow-up visit Other: Nasopharyngeal swab A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

Arm

Intervention/Treatment

Other: All patients

All patients included will be followed for 1 year, every 3 months

Other: Blood sample

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

Other: Expectoration

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

Other: Nasopharyngeal swab

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

Outcome Measures

Primary Outcome Measures

description of microbiomes from bronchoalveolar fluids [Inclusion]
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples [Inclusion]
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples [Inclusion]
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids [at 3 months]
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples [at 3 months]
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples [at 3 months]
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids [at 6 months]
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples [at 6 months]
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples [at 6 months]
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids [at 9 months]
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples [at 9 months]
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples [at 9 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: ËTAT Hortense, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT06044051

Other Study ID Numbers:

2023/0091/OB

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Rouen

microbiosme

Asthma in infant

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Sep 21, 2023