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
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
- 是
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)
