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

ConditionBronchiolitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants <12 months

With bronchiolitis during RSV epidemic season

No chronic illness

No bronchiolitis medical history

Disqualifiers

Chronic respiratory illness

Medical history of bronchiolitis or newborn asthma

Treatment with immunosuppressants

Patient with no social security affiliation

Trial population

Bronchiolitis in patient under 12 months old

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling

    Other intervention

    Single-time sampling of respiratory virus-infected children

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Severe bronchiolitis1 intervention
Group B: Non-hospitalized bronchiolitis1 intervention
Group C: Bronchiolitis ihospitalized in ICU0 interventions

Trial outcomes

Primary outcomes

1

Dysbiosis

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

Time frame
Inclusion

Secondary outcomes

1

Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma

Inflammatory/regulatory cytokines (IL1-\>17, IL-10, TGF-b, EGF, FGF-2, IFN-alpha, IFN-gamma, IFN-beta, MCRP-1 MCP-3, TNF-alpha...), cytokines of adaptative response (Th1, Th17, Th2 and/or Treg), markers of inflammatory response (interferon, TNFa, …), quantified by Luminex

Time frame
inclusion
2

Identifying the mRNA profile in blood samples and nasal swabs

mRNA will be identified by using RNA-Seq (Illumina)

Time frame
inclusion
3

Sequencing viral strains for mutation

Typing of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)

Time frame
Inclusion
4

Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection

Levels of RSV antibodies will be measured and compared between newborn screening specimen and capillary swab during infection

Time frame
Birth, Inclusion

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

Infectious Diseases Models for Innovative Therapies center

Collaborator