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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Quality of Life, Malnutrition, Growth Arrest

Intervention / Treatment
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* Dietary Supplement: Probiotic Microbial Composite
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Microbial Composite<br>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). | Dietary Supplement: Probiotic Microbial Composite<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years | 
| Height of healthy children aged 3 years to 12 years | Subjects will be followed by serial assessment of height in centimeters | 2 years | 
| Weight of healthy children aged 3 years to 12 years | Subjects will be followed by serial assessment of weight in kilograms | 2 years |