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临床试验/NCT00810160
NCT00810160已完成1 期

Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

University of California, Davis2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
59
试验地点
2
主要终点
To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria).

研究概览

简要总结

The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.

详细描述

To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria). In the initial phase of this trial, 30 premature infants will be randomly assigned to receive increasing doses of one of four dietary supplements: Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods), Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be examined by PCR to determine content of bifidobacteria and total bacteria. This study is limited to formula fed infants in order to avoid the confounding effects of the human milk oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate containing humna milk oligosaccharides) or powdered human milk fortifier for comparison

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

性别
All
接受健康志愿者

入选标准

  • Born in or transferred to UCDMC within the first two weeks of life. Birth weight less than 1500 grams. Gestational age less than 33 completed weeks. Exclusively formula fed.

排除标准

  • Gastrointestinal or cardiac anomalies.

研究组 & 干预措施

1

Active Comparator

Permeate

干预措施: ProlactPlus (Dietary Supplement)

2

Active Comparator

GOS

干预措施: GOS galacto-oligosaccharides (Dietary Supplement)

3

Active Comparator

Bifidobacterium infantis

干预措施: Bifidobacterium infantis (Dietary Supplement)

4

Active Comparator

Bifidobacterium animalis

干预措施: Bifidobacterium animalis (Dietary Supplement)

结局指标

主要结局

To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria).

时间窗: six weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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