Clinical trial Recruiting at 1 site Interventional Ages 1 Year to 3

Exploring the link between respiratory microbiome and severe asthma in young children

Official title: Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form

Run by University Hospital, Brest · NCT05192499 · Data updated 2026-11-12

This study is trying to see if the germs in the lungs of young children with severe asthma can help predict how well they respond to treatment.

Quick facts

Study typeInterventional
Ages1 Year to 3 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity Hospital, Brest
Academic / other
Locations1 site (Brest, Finistère)
StatusRecruiting
StartedFebruary 4, 2022
Main results expectedFebruary 4, 2028
Study endsFebruary 4, 2028
Registry record updatedSeptember 23, 2024
Trial IDNCT05192499 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 1 to 3 years diagnosed with asthma who have parental consent.

Probably not a fit

Patients with chronic pathologies such as cystic fibrosis or congenital heart disease, or those who have recently undergone antibiotic therapy, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between respiratory dysbiosis and severe asthma in preschool children under 3 years old. It aims to identify a microbiological signature that may predict corticosteroid resistance in these patients. The research employs a multicentric prospective case-control design, utilizing stool tests, blood tests, induced sputum, and nasal virology to gather data. The goal is to better understand how variations in the respiratory microbiome may influence asthma severity and treatment efficacy.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for young children with severe asthma, potentially reducing corticosteroid resistance.

How similar studies have gone: While the approach of using microbiota as a biomarker in asthma management is relatively novel, similar studies in cystic fibrosis have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age greater than 1 year and less than 3 years
* Diagnosis of asthma by a pediatrician
* Parental consent
* Affiliation to the social security system

Exclusion Criteria:

* Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery
* Premature \< 34 SA
* Recent antibiotic therapy (\< 7 days)
* Treatment with oral corticosteroid therapy within the previous 10 days.
* Patient whose parent(s) is (are) minor(s)

Where it's running

  • CHU de Brest
    Brest, Finistère, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.