NCT05192499 Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
| NCT ID | NCT05192499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-02-04 |
| Primary Completion | 2028-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-02-04 with a primary completion date of 2028-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children. Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotyping" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma. The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05192499 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 3 Years, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05192499 currently recruiting?
Yes, NCT05192499 is actively recruiting participants. Contact the research team at pierrick.cros@chu-brest.fr for enrollment information.
Where is the NCT05192499 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT05192499 clinical trial?
NCT05192499 is sponsored by University Hospital, Brest. The trial plans to enroll 30 participants.
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