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NCT Number: NCT06044051

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

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.

Recruiting

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Location status: Recruiting

Location contact

Hortense PETAT

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Expectoration

Other

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

Nasopharyngeal Swab

Other

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

Primary outcomes

  1. description of microbiomes from bronchoalveolar fluids

    Time frame: Inclusion

    analysis of bronchoalveolar fluids - NGS sequencing

  2. description of microbiomes from nasopharyngeal samples

    Time frame: Inclusion

    analysis of nasopharyngeal samples- NGS sequencing

  3. description of microbiomes from sputum samples

    Time frame: Inclusion

    analysis of sputum samples- NGS sequencing

  4. description of microbiomes from bronchoalveolar fluids

    Time frame: at 3 months

    analysis of bronchoalveolar fluids- NGS sequencing

  5. description of microbiomes from nasopharyngeal samples

    Time frame: at 3 months

    analysis of nasopharyngeal samples- NGS sequencing

  6. description of microbiomes from sputum samples

    Time frame: at 3 months

    analysis of sputum samples- NGS sequencing

  7. description of microbiomes from bronchoalveolar fluids

    Time frame: at 6 months

    analysis of bronchoalveolar fluids- NGS sequencing

  8. description of microbiomes from nasopharyngeal samples

    Time frame: at 6 months

    analysis of nasopharyngeal samples- NGS sequencing

  9. description of microbiomes from sputum samples

    Time frame: at 6 months

    analysis of sputum samples- NGS sequencing

  10. description of microbiomes from bronchoalveolar fluids

    Time frame: at 9 months

    analysis of bronchoalveolar fluids - NGS sequencing

  11. description of microbiomes from nasopharyngeal samples

    Time frame: at 9 months

    analysis of nasopharyngeal samples- NGS sequencing

  12. description of microbiomes from sputum samples

    Time frame: at 9 months

    analysis of sputum samples- NGS sequencing

  13. description of microbiomes from bronchoalveolar fluids

    Time frame: at 12 months

    analysis of bronchoalveolar fluids- NGS sequencing

  14. description of microbiomes from nasopharyngeal samples

    Time frame: at 12 months

    analysis of nasopharyngeal samples- NGS sequencing

  15. Description of microbiomes from sputum samples

    Time frame: at 12 months

    analysis of sputum samples- NGS sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

David Mallet

CONTACT

[email protected]

02 32 88 82 65 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: Microbiosthme

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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