此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Prebiotic Fiber to Prevent Pathogen Colonization in the ICU

2019年9月23日 更新者:Daniel Freedberg、Columbia University

Prebiotic Fiber to Prevent Pathogen Colonization in the Intensive Care Unit (ICU)

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10032
        • Columbia University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
See intervention description.
有源比较器: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.
See intervention description.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in microbiome measured by LEfSe
大体时间: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.
Baseline and Day 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Daniel E. Freedberg, MD, MS、Columbia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月16日

初级完成 (实际的)

2019年8月1日

研究完成 (实际的)

2019年8月1日

研究注册日期

首次提交

2018年4月17日

首先提交符合 QC 标准的

2018年4月17日

首次发布 (实际的)

2018年4月26日

研究记录更新

最后更新发布 (实际的)

2019年9月25日

上次提交的符合 QC 标准的更新

2019年9月23日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • AAAR5162
  • 1K23DK111847-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Sequencing data and corresponding metadata will be made available through the Short Read Archive (SRA) section of the National Center for Biotechnology Information (NCBI) at the time of publication of the study results.

IPD 共享时间框架

Data will be made available at the time of publication.

IPD 共享访问标准

Open.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

High Fiber的临床试验

3
订阅