Prebiotic Fiber to Prevent Pathogen Colonization in the Intensive Care Unit (ICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in microbiome measured by LEfSe
研究概览
简要总结
This is a pilot trial testing enteral feeds that are high versus low in prebiotic fiber in 20 critically ill adults. The long-term goal is to determine the efficacy of fiber for the prevention of pathogen colonization/infection in the ICU.
详细描述
This study will test prebiotic fiber in 20 adults who are receiving broad-spectrum antibiotics in the medical or surgical ICU by open-label randomization of patients to approximately 20 g prebiotic fiber/day including 45% short-chain fructooligosaccharides versus 0 g fiber/day by providing one of two feeds. Per 10 ounces of feed, both the high and low fiber feeds contain identical micronutrients and have 296 kilocalorie (kCal), 19 g protein, 8 g fat, and 39 g carbohydrates. The sole difference is that the fiber-containing feed has 4 g fiber including 45% short-chain fructooligosaccharides per 10 ounces whereas the other feed has 0 g fiber. Randomization will take place at the time the order for enteral feeding is placed. Rather than supplying the feed itself, the investigators will supply a randomized recommendation for a feed type (i.e., high vs low fiber) and the feed will be obtained from the hospital pharmacy in the usual manner. Determination of the feed rate and duration will be decided on the individual patient's needs by the treating ICU team. The primary outcome will be to determine whether high fiber feeds alter the gut microbiome in the face of antibiotics and critical illness, calculated by comparing within-individual microbiome differences from baseline to Day 3 in each intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical or surgical ICU patients ≥18 years old at our institution;
- •Receiving broad-spectrum antibiotics at the time of enrollment;
- •Deemed appropriate for the study by the treating ICU team;
- •With capacity to give consent or have an appropriate surrogate;
- •Able to undergo assessment within 4 hours of the order for enteral feeds;
- •Expected to receive enteral feeds for ≥3 days but not yet receiving them.
排除标准
- •Inability to receive enteral feeds;
- •Celiac disease or known allergy to fiber;
- •Surgery involving the intestinal lumen within 30 days;
- •Limited treatment goals (i.e., do-not-resuscitate (DNR), do-not-intubate (DNI), or no escalation of care);
- •Lack of capacity to consent and lack of an appropriate legally authorized representative.
研究组 & 干预措施
High Fiber
Per 10 ounces of feed: 4 g oat-soy fiber with 45% short-chain fructooligosaccharides, 296 kCal, 19 g protein, 8 g fat, and 39 g carbohydrates. Feed rate/duration individualized for each patient.
干预措施: High Fiber (Dietary Supplement)
Low Fiber
Per 10 ounces of feed: 0 g fiber, 296 kCal, 19 g protein, 8 g fat, and 39 g carbohydrates. Feed rate/duration individualized for each patient.
干预措施: Low Fiber (Dietary Supplement)
结局指标
主要结局
Change in microbiome measured by LEfSe
时间窗: Baseline and Day 3
An untargeted hierarchical linear discriminant analysis effect size algorithm (LEfSe) will be used to test for within-individual taxonomic differences comparing baseline to Day 3 in the high fiber group as it is an established method for identifying differences in bacterial taxa between any two groups. For those taxa which are significantly altered on LEfSe, the relative change in the high fiber group versus the relative change in the low fiber group will be computed using a rank-sum test.
次要结局
未报告次要终点
研究者
Daniel Freedberg
Assistant Professor of Medicine
Columbia University