RecruitingNot ApplicableNCT05192499

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


Sponsor

University Hospital, Brest

Enrollment

30 participants

Start Date

Feb 4, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the bacteria that live in the airways of very young children with asthma to see whether an imbalance in these bacteria (called dysbiosis) can predict which children will develop a more severe form of asthma. It is an observational study — no experimental treatments are given. **You may be eligible if...** - Your child is between 1 and 3 years old - Your child has been diagnosed with asthma by a pediatrician - You (as parent) consent to participation - Your child has health insurance coverage (French social security affiliation) **You may NOT be eligible if...** - Your child has a serious chronic condition such as congenital heart disease, cystic fibrosis, immune deficiency, or a significant digestive disorder requiring surgery - Your child was born before 34 weeks of pregnancy - Your child has received antibiotics within the last 7 days - Your child has taken oral steroids within the last 10 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStool test

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

PROCEDUREBlood test

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

PROCEDUREInduced 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).

PROCEDUREnasale 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.


Locations(1)

CHU de Brest

Brest, Finistère, France

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NCT05192499


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