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

Bronchiolitis Clinical Trial

— BRONCHOBIOTE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06161285
• Other study ID #: APHP231177
• Secondary ID: 2023-A01688-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Etienne BIZOT, Doctor
• Phone: 33145374618
• Email: etienne.bizot[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Dysbiosis

Intervention

Other:
• Sampling
Single-time sampling of respiratory virus-infected children

Locations

Country	Name	City	State
France	APHP, Antoine Béclère Hospital	Clamart
France	AP-HP,Raymond Poincaré Hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Infectious Diseases Models for Innovative Therapies center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Identifying the mRNA profile in blood samples and nasal swabs	mRNA will be identified by using RNA-Seq (Illumina)	inclusion
Secondary	Sequencing viral strains for mutation	Typing of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)	Inclusion
Secondary	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