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临床试验/NCT00118872
NCT00118872已完成不适用

Feasibility Study of Probiotics for Growth Faltering in Pakistan

Tufts University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Growth, as measured by weight for age and height

研究概览

简要总结

This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.

Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.

详细描述

Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.

Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.

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
1 Week 至 5 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Born and reside in Bilal Colony, Karachi Pakistan during the study
  • Parent or guardian willing to provide informed consent
  • Parent or guardian willing to permit home visits
  • Predominantly breastfed at study start

排除标准

  • Malnutrition at time of weaning
  • Medical condition that would affect response to LGG

研究组 & 干预措施

LGG yogurt

Active Comparator

Lactobacillus (LGG) containing yogurt

干预措施: Placebo yogurt (Other)

LGG yogurt

Active Comparator

Lactobacillus (LGG) containing yogurt

干预措施: LGG yogurt (Drug)

Placebo yogurt

Placebo Comparator

Regular yogurt, NOT containing LGG

干预措施: Placebo yogurt (Other)

结局指标

主要结局

Growth, as measured by weight for age and height

时间窗: 3 months

次要结局

  • Number of episodes of diarrhea(3 months)
  • duration of episodes of diarrhea(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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