Exploring the link between respiratory microbiome and severe asthma in young children
Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
NA · University Hospital, Brest · NCT05192499
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest, Finistère) |
| Trial ID | NCT05192499 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 3 years diagnosed with asthma who have parental consent.
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.
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 performed: While the approach of using microbiota as a biomarker in asthma management is relatively novel, similar studies in cystic fibrosis have shown promising results.
Eligibility criteria
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 this trial is running
Brest, Finistère
- CHU de Brest — Brest, Finistère, France (RECRUITING)
Study contacts
- Study coordinator: Pierrick CROS
- Email: pierrick.cros@chu-brest.fr
- Phone: 02 98 22 36 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma in Children, Dysbiosis, Paediatric Pulmonology, asthma, respiratory microbiome