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临床试验/NCT03414775
NCT03414775已完成不适用

Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Changes to the gastrointestinal microbiome

研究概览

简要总结

This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.

详细描述

The gastrointestinal microbiome has been shown to be altered in critically-ill children such that there is a larger shift toward pathogenic bacteria. Previous studies have shown that probiotics, fecal transplants, antibiotic decontamination, and dietary interventions can shift the gastrointestinal microbiome toward a metabolically favorable microbiome profile and be associated with improvements in disease burden.

This study will randomize critically-ill children who are stable enough for enteral tube feedings to receive either Pediasure or Nourish. Pediasure is a commercially-made formula that is used commonly in pediatric patients. Nourish is an organic, whole-food formula with a high fiber content. High-fiber diets have been correlated with metabolically favorable microbiome profiles. This study will look at the microbiome before and after initiation of enteral tube feedings to determine if either formula is associated with a shift in the microbiome toward a favorable profile.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Admitted to the pediatric intensive care unit
  • Age 1-17 years old
  • Previously placed enteric tube designed for enteric feeding

排除标准

  • Vasoactive medication use
  • History of allergies or intolerances to either Pediasure or Nourish
  • Whey allergy or intolerance
  • Gluten sensitivity or intolerance
  • Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)

研究组 & 干预措施

Pediasure

Active Comparator

Patients assigned to this arm will receive Pediasure

干预措施: Pediasure (Other)

Nourish

Active Comparator

Patients assigned to this arm will receive Nourish

干预措施: Nourish (Other)

结局指标

主要结局

Changes to the gastrointestinal microbiome

时间窗: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis

次要结局

  • Concentration of short-chain fatty acids(Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajesh Aneja

Associate Professor

University of Pittsburgh

研究点 (1)

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