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

May 10, 2017 updated by: Biowish Technologies, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mysore, Karnataka, India, 570 001
        • Mysore Medical College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Dietary supplement: Probiotic Microbial Composite
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.
Placebo Comparator: 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.
Dietary supplement: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute diarrhea in children ages 3 years to 12 years
Time Frame: 24 weeks
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
Time Frame: 2 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
Time Frame: 2 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
Time Frame: 2 years
Subjects will be followed by serial assessment of height in centimeters
2 years
Weight of healthy children aged 3 years to 12 years
Time Frame: 2 years
Subjects will be followed by serial assessment of weight in kilograms
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biowish Technologies, Inc.

Collaborators

University of Wollongong
Mysore Medical College and Research Institute

Investigators

  • Principal Investigator: Mudassir A Khan, Ph.D., Department of Community Medicine/Public Health Mysore Medical College & Research Institute
  • Principal Investigator: Amit Kapur, MBBS, Prince of Wales Hospital
  • Principal Investigator: Richard S Carpenter, PhD, Biowish Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWT-20150720-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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