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

NCT07417657 | Not Yet Recruiting

• 1 other identifier: 41/BVNTW-HĐĐĐ
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

RSV; gut microbiome; 16S rRNA; Gut-lung axis; Vietnam; infants; Biomarkers; Bronchiolitis; Lower respiratory tract infection

Outcome Measures

Primary Outcomes (1)

• Association between gut microbiome diversity/composition and RSV severity

  Differences in gut microbiome diversity and taxonomic composition assessed by 16S rRNA sequencing (alpha diversity, beta diversity, and differential taxa abundance) between severe and mild RSV groups

  Within 24 hours of hospital admission

Secondary Outcomes (4)

• Systemic cytokine response in severe versus mild RSV infection

  Within 24 hours of hospital admission

• Clinical severity scores in RSV infection measured by Pediatric Sequential Organ Failure Assessment (pSOFA) Score

  within 24 h of hospitalization

• Integrated microbiome-immune signature predicting severe RSV

  Baseline (first 24h) predicting severity classification during index hospitalization

• ICU resource utilization

  Up to day 28

Study Arms (1)

Severe RSV group: infants requiring HFNC/CPAP/invasive ventilation and/or PICU admission

Mild RSV group: infants requiring no respiratory support or low-flow oxygen ≤2 L/min via nasal cannula

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with acute lower respiratory tract infection and RT-PCR-confirmed RSV presenting to Vietnam National Children's Hospital

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

Sponsors & Collaborators

• Phuc Huu Phan: lead

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool microbiome DNA + serum/plasma for cytokines

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Bronchiolitis

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Phuc H Phan, M.D.

CONTACT

+84912880105; phucph@nch.gov.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)