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Clinical Trials in France / NCT05192499
Recruiting Not applicable

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

NCT05192499 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-02-04
Last updated
2024-09-23

Condition(s) studied

Asthma in ChildrenDysbiosis

Investigational drug(s) / intervention(s)

Stool testBlood testInduced sputumnasale virology

Stool test: At inclusion (day 0), stools will be collected with a kit for to remove to 5 mg for each patient.

Blood test: Blood sample taken during inclusion (day 0) will be collected. There is between 19 and 26 mL for each patient.

Induced sputum: At inclusion (day 0), bronchial aspiration after inhalation induction of 4 mL of 6% salt serum administered (after 200 μg of salbutamol via an inhalation chamber during a bronchial drainage session).

nasale virology: At inclusion (Day 0), patients will be taken nasal swab for virology with swab adapted for nasal swab or with suction trap when blowing the child's nose (depending on center practice)and multiplex PCR.

Study 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

Sex
ALL
Min age
1 Year
Max age
3 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Brest Brest Finistère Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05192499 on ClinicalTrials.gov ↗ ← All trials in France