Quality of Life Clinical Trial
Official title:
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
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.
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.
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