Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in microbiome longitudinally
研究概览
简要总结
This study plans to learn more about the impact of enteral nutrition on bacteria in critically ill trauma patients with brain injury. Specifically, it seeks to understand the effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the U.S. Food and Drug Administration and is not considered investigational as used in this study. Enteral feeding is a way to give nutrition to critically ill people who are unable to eat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult major neurological injury trauma patients between 18-70 years of age who have been admitted directly to trauma ICU following major trauma
- •Expected length of mechanical ventilation > 48 hours (as judged by admitting clinician)
- •Expected length of ICU stay > 3 days (as judged by admitting clinician)
- •Expected to survive > 48 hours (as judged by admitting clinician)
- •Requiring enteral nutrition at any time in Intensive Care Unit (ICU) stay
- •Chronic illnesses must be under control (as determined by the Principal Investigator).
排除标准
- •Previous hospitalization within one month prior to ICU admission (no hospital floor transfers to eliminate confounding effect of previous hospital therapy)
- •Use of prebiotic fiber containing enteral or oral formula or probiotic preparations within one week
- •Received antibiotics within the previous month
- •On steroids or immunosuppressants at time of admission
- •All transplant patients
- •Chronic inflammatory disease that requires steroids or other biologic therapy intervention (e.g.: RA, IBD that requires steroids or Humira)
- •Undergoing active chemotherapy/radiation treatment
- •Renal failure requiring dialysis
- •Liver cirrhosis class C
结局指标
主要结局
Change in microbiome longitudinally
时间窗: Baseline at Day 2, 4, 6, 8 and 10
Tongue swab microbiome longitudinally
Changes in the microbiome on delivery of initial clinical outcomes in trauma patients
时间窗: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
Changes in microbiome
时间窗: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
Overall microbiome composition sampling gut
时间窗: Baseline (within 48 hours of ICU admission), up to 10 days
Stool samples
次要结局
- Record length of mechanical ventilation(Up to 60 days)
- Length of hospital stay(Up to 60 days)
- Mortality(Up to 60 days)
- Length of ICU(Up to 60 days)