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

February 13, 2026 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Rouen, France
        • Recruiting
        • Rouen University Hospital
        • Contact:
          • Hortense PETAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of microbiomes from bronchoalveolar fluids
Time Frame: Inclusion
analysis of bronchoalveolar fluids - NGS sequencing
Inclusion
description of microbiomes from nasopharyngeal samples
Time Frame: Inclusion
analysis of nasopharyngeal samples- NGS sequencing
Inclusion
description of microbiomes from sputum samples
Time Frame: Inclusion
analysis of sputum samples- NGS sequencing
Inclusion
description of microbiomes from bronchoalveolar fluids
Time Frame: at 3 months
analysis of bronchoalveolar fluids- NGS sequencing
at 3 months
description of microbiomes from nasopharyngeal samples
Time Frame: at 3 months
analysis of nasopharyngeal samples- NGS sequencing
at 3 months
description of microbiomes from sputum samples
Time Frame: at 3 months
analysis of sputum samples- NGS sequencing
at 3 months
description of microbiomes from bronchoalveolar fluids
Time Frame: at 6 months
analysis of bronchoalveolar fluids- NGS sequencing
at 6 months
description of microbiomes from nasopharyngeal samples
Time Frame: at 6 months
analysis of nasopharyngeal samples- NGS sequencing
at 6 months
description of microbiomes from sputum samples
Time Frame: at 6 months
analysis of sputum samples- NGS sequencing
at 6 months
description of microbiomes from bronchoalveolar fluids
Time Frame: at 9 months
analysis of bronchoalveolar fluids - NGS sequencing
at 9 months
description of microbiomes from nasopharyngeal samples
Time Frame: at 9 months
analysis of nasopharyngeal samples- NGS sequencing
at 9 months
description of microbiomes from sputum samples
Time Frame: at 9 months
analysis of sputum samples- NGS sequencing
at 9 months
description of microbiomes from bronchoalveolar fluids
Time Frame: at 12 months
analysis of bronchoalveolar fluids- NGS sequencing
at 12 months
description of microbiomes from nasopharyngeal samples
Time Frame: at 12 months
analysis of nasopharyngeal samples- NGS sequencing
at 12 months
Description of microbiomes from sputum samples
Time Frame: at 12 months
analysis of sputum samples- NGS sequencing
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: PETAT Hortense, University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

September 26, 2026

Study Completion (Estimated)

September 26, 2026

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0091/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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