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Clinical Trials/NCT06161285
NCT06161285RecruitingNot Applicable

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

Assistance Publique - Hôpitaux de Paris3 sites in 1 country120 target enrollmentStarted: December 6, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
3
Primary Endpoint
Dysbiosis

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Day to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Dysbiosis

Time Frame: Inclusion

comparison of the quantitative and qualitative composition of bacteria (alpha diversity, beta diversity, Shannon and Simpson index) in the digestive and nasopharyngeal microbiota

Secondary Outcomes

  • Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma(inclusion)
  • Identifying the mRNA profile in blood samples and nasal swabs(inclusion)
  • Sequencing viral strains for mutation(Inclusion)
  • Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection(Birth, Inclusion)
  • Study the load of Streptococcus pneumoniae (Sp) in RSV infections.(Inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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