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

NCT06161285 | Recruiting

• 2 other identifiers: APHP2311772023-A01688-37
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchiolitis

Keywords

Newborns; Dysbiosis; respiratory syncytial virus (RSV)

Outcome Measures

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

  Inclusion

Secondary Outcomes (5)

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

  inclusion

• Identifying the mRNA profile in blood samples and nasal swabs

  inclusion

• Sequencing viral strains for mutation

  Inclusion

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

  Birth, Inclusion

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

  Inclusion

Study Arms (3)

Severe bronchiolitis

venous blood samples. Buccal, nasopharyngeal and rectal swabs

Other: Sampling

Non-hospitalized bronchiolitis

Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

Other: Sampling

Bronchiolitis ihospitalized in ICU

Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

Interventions

Sampling OTHER

Single-time sampling of respiratory virus-infected children

Non-hospitalized bronchiolitis; Severe bronchiolitis

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Bronchiolitis in patient under 12 months old

You may qualify if:

• Infants \<12 months
• With bronchiolitis during RSV epidemic season
• No chronic illness
• No bronchiolitis medical history
• Signed consent from parents or legal guardians

You may not qualify if:

• Chronic respiratory illness
• Medical history of bronchiolitis or newborn asthma
• Treatment with immunosuppressants
• Patient with no social security affiliation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Infectious Diseases Models for Innovative Therapies center: collaborator

Study Sites (3)

APHP, Antoine Béclère Hospital

Clamart, 92140, France

RECRUITING

AP-HP,Raymond Poincaré Hospital

Garches, 92380, France

RECRUITING

Réanimation médico-chirurgicale Necker

Paris, 750, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis; Dysbiosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Etienne BIZOT, Doctor

  AP-HP Hôpital Antoine Beclere

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne BIZOT, Doctor

CONTACT

33145374618; etienne.bizot@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: December 6, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)