Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
Clinical Study of Novel Probiotic Microbial Composite™ to Treat 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.
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

 Exclusion criteria:

 -  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.