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临床试验/NCT03150927
NCT03150927Unknown不适用

A Clinical Study to Determine the Effects of a Novel Probiotic Microbial Composite™ on Improving Digestive Health and Key Growth Parameters in Undernourished Young Children

Biowish Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
2
主要终点
Acute diarrhea in children ages 3 years to 12 years

研究概览

简要总结

This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the digestive health and subsequent growth and quality of life parameters in a selected group of children in a district in India.

详细描述

The Probiotic Microbial Composite™ is a multifaceted technology that encompasses three key areas, namely, prebiotics, probiotics and post-biotics. The first component, prebiotics, involve non-digestible food ingredients, typically oligosaccharides which act by beneficially affecting the host by stimulating growth, activity, or in fact both of specific intestinal bacteria.

The probiotic component refers to the augmentation or addition of bacteria to enhance and support the various beneficial bacteria that are inherent to the gastrointestinal tract. The bio-fermented Microbiotic Composite™ is a consortium of bacteria which can play a significant physiological role as a probiotic. This theory, termed the microbial consortium theory suggests that rather than a cumulative effect by the bacteria, there is in fact combinatorial affect by the use of several species.

The final component post-biotics, in general, mimic the beneficial health promoting effects of probiotics whilst avoiding the risk of taking live micro-organisms within the gastrointestinal tract, especially in populations such as infants and the elderly in whom the intestinal barriers, as well as, innate immune defenses can be impaired. The term typically encompasses a vast plethora of byproducts, know as metabolites, produced and secreted by the bacteria in response to their environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Product will be given to subjects in a capsule form. Participant and participants legal guardians, and care providers will not know if the capsule is a placebo or the Probiotic Microbial Composite™

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Acute diarrhea in children ages 3 years to 12 years

时间窗: 24 weeks

Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics

次要结局

  • Weight of healthy children aged 3 years to 12 years(2 years)
  • Height of healthy children aged 3 years to 12 years(2 years)
  • Serial assessment of healthy children aged 3 years to 12 years(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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