Examining the link between gut bacteria and immune response in infants with bronchiolitis
Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
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 type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 12 Months |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Clamart and 2 other locations) |
| Trial ID | NCT06161285 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants under 12 months with bronchiolitis during the RSV epidemic season and without chronic illnesses or prior bronchiolitis history.
Not a fit: Patients with chronic respiratory illnesses, a history of bronchiolitis, or those receiving immunosuppressive treatments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Clamart and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.