Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity Hospital, Brest
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age greater than 1 year and less than 3 years
Diagnosis of asthma by a pediatrician
Parental consent
Affiliation to the social security system
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Stool test
Procedure/SurgeryAt inclusion (day 0), stools will be collected with a kit for to remove to 5 mg for each patient.
Blood test
Procedure/SurgeryBlood sample taken during inclusion (day 0) will be collected. There is between 19 and 26 mL for each patient.
Induced sputum
Procedure/SurgeryAt 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
Procedure/SurgeryAt 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: CaseOther 4 interventions
Group B: ControlOther 4 interventions
Trial outcomes
Primary outcomes
1
Number of species in the microbial Community
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such as alpha diversity. Alpha diversity calculates the richness (number of species or OTU) by samples and how these OTUs are distributed (equitability). Richness will be measured with the Chao1 and equity with the Simpson index. The Shannon index is a composite measurethat allows us to have both information together, richness and equity in the same index.
Time frame
Day 02
Index of microbial similarity of samples
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such beta diversity. Beta diversity analysis allows samples to be compared with each other. It calculates a matrix of distances between samples with the Bray Curtis/ Unifrac methods, weighted or not/ Jaccard by presence/absence. Next, the Principal Coordinate Analysis (PCoA ) will be used, multidimensional scaling to reduce this matrix to 2/3 dimensions. The samples from similar groups look alike with this analysis will be used.
Time frame
Day 0Secondary outcomes
1
Enterotyping analysis
Characterization of bacterial pulmotypes by so-called "enterotyping" analysis in asthmatic children under 36 months of age. The enterotyping technique is a multifactorial technique that aims to group species / OTUs regularly found together. Enterotypes can characterize states of health or dysbiosis in the lung or intestines. OTU groups are used to classify individuals according to their lung / intestinal bacteria. The enterotypes / pulmotypes are considered already present in the literature and use PCA-type analyses to identify these groups of OTUs.
Time frame
Day 02
Relative abundance
Relative abundance (expressed as a percentage) of each of the identified bacteriological taxa
Time frame
Day 03
Indices of diversity
Types of indices of diversity of bacterial taxa identified in the digestive microbiota
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov