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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06161285
Acronym
BRONCHOBIOTE
Enrollment
120
Registered
2023-12-07
Start date
2024-12-06
Completion date
2026-04-30
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Newborns, Dysbiosis, respiratory syncytial virus (RSV)

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.

Interventions

OTHERSampling

Single-time sampling of respiratory virus-infected children

Sponsors

Infectious Diseases Models for Innovative Therapies center
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 12 Months
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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasmainclusionInflammatory/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
Identifying the mRNA profile in blood samples and nasal swabsinclusionmRNA will be identified by using RNA-Seq (Illumina)
Sequencing viral strains for mutationInclusionTyping of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)
Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infectionBirth, InclusionLevels of RSV antibodies will be measured and compared between newborn screening specimen and capillary swab during infection
Study the load of Streptococcus pneumoniae (Sp) in RSV infections.InclusionCompare the serotypic profiles of pneumococcus (Sp) present during RSV infections

Countries

France

Contacts

Primary ContactEtienne BIZOT, Doctor
etienne.bizot@aphp.fr33145374618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026