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NCT Number: NCT06161285

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

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Dysbiosis Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP, Antoine Béclère Hospital, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling

Other

Single-time sampling of respiratory virus-infected children

Primary outcomes

  1. 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

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

    Time frame: inclusion

    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

  2. Identifying the mRNA profile in blood samples and nasal swabs

    Time frame: inclusion

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

  3. Sequencing viral strains for mutation

    Time frame: Inclusion

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

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

    Time frame: Birth, Inclusion

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

  5. Study the load of Streptococcus pneumoniae (Sp) in RSV infections.

    Time frame: Inclusion

    Compare the serotypic profiles of pneumococcus (Sp) present during RSV infections

Study contacts

Contact information is provided by the study sponsor or research team.

Etienne BIZOT, Doctor

CONTACT

[email protected]

33145374618

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Infectious Diseases Models for Innovative Therapies center

Registry information

Acronym: BRONCHOBIOTE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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