NCT07417657

Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants

Impact of the Gut Microbiome on Immune Response and Disease Severity in Acute Respiratory Syncytial Virus (RSV) Infection in Vietnamese Children: A Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Phuc Huu Phan · Academic / Other
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, prospective observational study conducted at Vietnam National Children's Hospital in Hanoi over 48 months. Approximately 250 infants aged 1-24 months with RT-PCR-confirmed RSV lower respiratory tract infection will be enrolled and classified into severe vs mild groups based on need for advanced respiratory support (HFNC/CPAP/invasive ventilation) and/or PICU admission versus no/low-flow oxygen requirement. Stool samples collected within the first 24 hours of admission will undergo 16S rRNA sequencing (V3-V4 region) to characterize gut microbiome diversity and taxa abundance. Blood samples collected within the first 24 hours will be used to quantify key cytokines (e.g., TNF-α, IL-6, IL-8, IL-1β, IFN-γ, IL-10, IL-17A, IL-22) using ELISA; immune cell subsets may be assessed by flow cytometry. Clinical severity will be assessed using standardized pediatric scores (PRISM III, PELOD, pSOFA) and treatment outcomes will be recorded. The study will evaluate associations among microbiome features, immune response markers, and RSV severity to propose candidate integrated biomarkers for early risk stratification.

Conditions

• Respiratory Syncytial Virus Infection
• Bronchiolitis
• Viral Lower Respiratory Tract Infection (LRTI)

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Vietnam