NCT05192499Recruiting
Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
Source: ClinicalTrials.gov · Last updated 23 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Nov 2021
- Start date
- 4 Feb 2022
- Primary completion date
- 4 Feb 2028
- Lead sponsor
- University Hospital, Brest
- Diseases
- Asthma
- NCT number
- NCT05192499
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 4 Feb 2022 to the primary completion date, 4 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent antibiotic therapy (\< 7 days)
- Treatment with oral corticosteroid therapy within the previous 10 days.
Other illness
- Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery
Other
- Premature \< 34 SA
- Patient whose parent(s) is (are) minor(s)
Who the study is looking for
- Age greater than 1 year and less than 3 years
- Diagnosis of asthma by a pediatrician
- Parental consent
- Affiliation to the social security system
Age in the registry: 1 year to 3 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.