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

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 Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Sampling

• Study Type: Observational
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Etienne BIZOT, Doctor; Phone Number: 33145374618; Email: etienne.bizot@aphp.fr

Study Locations

• France
  • Clamart, France, 92140
    • Recruiting
    • APHP, Antoine Béclère Hospital
    • Contact: Etienne BIZOT, Doctor; Phone Number: 33145374618; Email: etienne.bizot@aphp.fr
  • Garches, France, 92380
    • Recruiting
    • AP-HP,Raymond Poincaré Hospital
    • Contact: Justine ZINI, Doctor; Phone Number: 33147107880; Email: justine.zini@aphp.fr
  • Paris, France, 750
    • Recruiting
    • Réanimation médico-chirurgicale Necker
    • Contact: Charlotte Collignon, Dr; Phone Number: 95890; Email: charlotte.collignon@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Bronchiolitis in patient under 12 months old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe bronchiolitis; venous blood samples. Buccal, nasopharyngeal and rectal swabs	Other: Sampling; Single-time sampling of respiratory virus-infected children
Non-hospitalized bronchiolitis; Capillary blood samples. Buccal, nasopharyngeal and rectal swabs	Other: Sampling; Single-time sampling of respiratory virus-infected children
Bronchiolitis ihospitalized in ICU; Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysbiosis	comparison of the quantitative and qualitative composition of bacteria (alpha diversity, beta diversity, Shannon and Simpson index) in the digestive and nasopharyngeal microbiota	Inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	inclusion
Identifying the mRNA profile in blood samples and nasal swabs	mRNA will be identified by using RNA-Seq (Illumina)	inclusion
Sequencing viral strains for mutation	Typing of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)	Inclusion
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	Birth, Inclusion
Study the load of Streptococcus pneumoniae (Sp) in RSV infections.	Compare the serotypic profiles of pneumococcus (Sp) present during RSV infections	Inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Infectious Diseases Models for Innovative Therapies center
• Investigators: Principal Investigator: Etienne BIZOT, Doctor, AP-HP Hôpital Antoine Beclere

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Newborns; Dysbiosis; respiratory syncytial virus (RSV)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Dysbiosis; Bronchiolitis
• Other Study ID Numbers: APHP231177; 2023-A01688-37 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No