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

Not Applicable

• Conditions: Malnutrition; Quality of Life; Growth Arrest
• Interventions: Dietary Supplement: Probiotic Microbial Composite; Dietary Supplement: Placebo

• Registration Number: NCT03150927
• Lead Sponsor: Biowish Technologies, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-05
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Study First Posted: 2017-05-12
• Last Update Posted: 2017-05-12
• Study Start: 2017-09
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Microbial Composite	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).
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Acute diarrhea in children ages 3 years to 12 years	24 weeks	Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics

Secondary Outcome Measures

Name	Time	Method
Weight of healthy children aged 3 years to 12 years	2 years	Subjects will be followed by serial assessment of weight in kilograms
Serial assessment of healthy children aged 3 years to 12 years	2 years	Subjects will be followed by serial assessment of head circumference measured in centimeters.
Height of healthy children aged 3 years to 12 years	2 years	Subjects will be followed by serial assessment of height in centimeters

Trial Locations

Locations (1)

Mysore Medical College and Research Institute; 🇮🇳 Mysore, Karnataka, India