Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Respiratory Syncytial Virus Infection, Bronchiolitis, Viral Lower Respiratory Tract Infection (LRTI). Basic parameters: 1 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Association between gut microbiome diversity/composition and RSV severity [Time frame: Within 24 hours of hospital admission]
Secondary outcome measures (4)
- Systemic cytokine response in severe versus mild RSV infection [Time frame: Within 24 hours of hospital admission]
- Clinical severity scores in RSV infection measured by Pediatric Sequential Organ Failure Assessment (pSOFA) Score [Time frame: within 24 h of hospitalization]
- Integrated microbiome-immune signature predicting severe RSV [Time frame: Baseline (first 24h) predicting severity classification during index hospitalization]
- ICU resource utilization [Time frame: Up to day 28]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- Vietnam National Children's Hospital — Hanoi
Identifiers
NCT: NCT07417657 · 41/BVNTW-HĐĐĐ