Clinical trial Recruiting at 3 sites Observational Ages 1 Day to 12 Months

Examining the link between gut bacteria and immune response in infants with bronchiolitis

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

Run by Assistance Publique - Hôpitaux de Paris · NCT06161285 · Data updated 2026-11-12

This study is trying to see how the balance of gut bacteria affects the immune response in infants with bronchiolitis caused by RSV.

Quick facts

Study typeObservational
Ages1 Day to 12 Months
SexAll
Enrollment120 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations3 sites (Clamart and 2 other locations)
StatusRecruiting
StartedDecember 6, 2024
Main results expectedMarch 2026
Study endsApril 2026
Registry record updatedFebruary 26, 2025
Trial IDNCT06161285 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants under 12 months with bronchiolitis during the RSV epidemic season and without chronic illnesses or prior bronchiolitis history.

Probably not a fit

Patients with chronic respiratory illnesses, a history of bronchiolitis, or those receiving immunosuppressive treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between dysbiosis, or microbial imbalance, and immune responses in infants under 12 months suffering from bronchiolitis, primarily caused by respiratory syncytial virus (RSV). The study will enroll 80 infants, both hospitalized and non-hospitalized, during the RSV epidemic season. Researchers will collect oral, nasal, and stool samples to analyze the microbiota and a capillary blood sample for immune response evaluation. The goal is to better understand how these factors influence the severity and progression of bronchiolitis.

Why it matters

Potential benefit: If successful, this study could lead to improved predictive models for the severity of bronchiolitis in infants, potentially guiding more effective treatments.

How similar studies have gone: While the specific approach of this study may be novel, previous studies have indicated a significant relationship between microbiota and immune responses in respiratory infections.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • APHP, Antoine Béclère Hospital
    Clamart, France
    Recruiting
  • AP-HP,Raymond Poincaré Hospital
    Garches, France
    Recruiting
  • Réanimation médico-chirurgicale Necker
    Paris, France
    Recruiting

Study contacts

  • Principal investigator: Etienne BIZOT, Doctor — AP-HP Hôpital Antoine Beclere
  • Study coordinator: Etienne BIZOT, Doctor
  • Email: etienne.bizot@aphp.fr
  • Phone: 33145374618

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.