Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sampling.
- Who it may be relevant to
- Registry conditions: Bronchiolitis. Basic parameters: 1 Day — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.
Interventions
- Other Sampling
Single-time sampling of respiratory virus-infected children
Primary outcome measures
- Dysbiosis [Time frame: Inclusion]
Secondary outcome measures (5)
- Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma [Time frame: inclusion]
- Identifying the mRNA profile in blood samples and nasal swabs [Time frame: inclusion]
- Sequencing viral strains for mutation [Time frame: Inclusion]
- Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection [Time frame: Birth, Inclusion]
- Study the load of Streptococcus pneumoniae (Sp) in RSV infections. [Time frame: Inclusion]
Eligibility criteria
Inclusion criteria
- Infants <12 months
- With bronchiolitis during RSV epidemic season
- No chronic illness
- No bronchiolitis medical history
- Signed consent from parents or legal guardians
Exclusion criteria
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient with no social security affiliation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 3 centers
- APHP, Antoine Béclère Hospital — Clamart
- AP-HP,Raymond Poincaré Hospital — Garches
- Réanimation médico-chirurgicale Necker — Paris
Identifiers
NCT: NCT06161285 · APHP231177 · 2023-A01688-37