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
- 1
- 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
- •The Randomized Clinical Trial (RCT) will typically involve 250 subjects randomized into two arms based on age and sex.
- •Following a positive outcome in the RCT (following 6 months), we envisage converting the study to an observational based study (case-study) based on ethical principles where the placebo arm of the study would be administered the test product. Each subject will be assessed for a total of two years.
- •Inclusion criteria:
- •Inpatient setting: Children with age of 3 years to 12 years with acute diarrhea
- •Outpatient setting: healthy children aged 3 years to 12 years
排除标准
- •Subjects taking any kind of prescription medication.
- •Subjects taking any dietary supplements (2-week washout is permitted).
- •Subjects taking any antibiotics (must have discontinued antibiotic use 12-weeks prior to beginning study). An allowance will be made to existing subjects already taking part in the study. This confounder will however have to be noted by the primary investigators.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
- •Including subjects who are bed or wheelchair-bound
- •Including subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
研究组 & 干预措施
Probiotic Microbial Composite
Probiotic Microbial Composite is a safe, 100% natural material containing all Generally Recognized as Safe (GRAS) Probiotics, combined with FDA approved food grade excipient materials. The probiotics contained within are also all 100% natural and non-Genetically Modified Organisms (non-GMO).
干预措施: Probiotic Microbial Composite (Dietary Supplement)
Placebo
Placebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable.
干预措施: Placebo (Dietary Supplement)
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
- Serial assessment of healthy children aged 3 years to 12 years(2 years)
- Height of healthy children aged 3 years to 12 years(2 years)
- Weight of healthy children aged 3 years to 12 years(2 years)