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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
125mg (or 250 mg) of BiOWiSH Probiotic Microbial Composite™ is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
125mg (or 250 mg) of Placebo is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
Mysore Medical College and Research Institute
Mysore, Karnataka, India
Acute diarrhea in children ages 3 years to 12 years
Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics
Time frame: 24 weeks
Serial assessment of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of mid-arm circumference measured in centimeters.
Time frame: 2 years
Serial assessment of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of head circumference measured in centimeters.
Time frame: 2 years
Height of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of height in centimeters
Time frame: 2 years
Weight of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of weight in kilograms
Time frame: 2 years
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