Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
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Conditions studied: Respiratory Syncytial Virus Infection, Bronchiolitis, Viral Lower Respiratory Tract Infection (LRTI)
In brief
Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infection in young children, and a substantial proportion of severe cases occur in previously healthy infants. The gut-lung axis suggests that gut microbiome composition may modulate respiratory immune responses. This prospective observational study in Vietnam will compare gut microbiome profiles and systemic immune cytokine responses between infants with severe RSV infection and those with mild RSV infection, aiming to identify microbiome-immune signatures associated with disease severity.
Key facts
- Study ID
- NCT07417657
- Run by
- Phuc Huu Phan
- People needed
- 250
- Starts
- 2026-04-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-02-18
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 1 to 24 months RT-PCR positive for RSV from respiratory specimen Symptoms consistent with acute lower respiratory tract infection Parent/legal guardian provides informed consent
You may not qualify if…
- Prematurity <32 weeks gestation or birthweight <1500 g Chronic conditions (e.g., congenital heart disease, chronic lung disease, chronic liver/kidney disease) Primary or acquired immunodeficiency Severe malnutrition (weight-for-age Z-score < -3 SD) Antibiotic use within 2 weeks before admission Probiotic use within 4 weeks before admission Co-infection with other pathogens (viral/bacterial) Stool sample not obtained within 24 hours of admission
Where it is running
- Vietnam National Children's Hospital — Hanoi, Vietnam
Full record on ClinicalTrials.gov
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