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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Association between gut microbiome diversity/composition and RSV severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Association between gut microbiome diversity/composition and RSV severity
时间窗: Within 24 hours of hospital admission
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
次要结局
- 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)
研究者
Phuc Huu Phan
Principle Investigator
National Children's Hospital, Vietnam