Back to resultsClinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
Primary Purpose
Quality of Life, Malnutrition, Growth Arrest
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Probiotic Microbial Composite
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life
Eligibility Criteria
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.
Sites / Locations
- Mysore Medical College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic Microbial Composite
Placebo
Arm Description
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 is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Serial assessment of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of head circumference measured in centimeters.
Height of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of height in centimeters
Weight of healthy children aged 3 years to 12 years
Subjects will be followed by serial assessment of weight in kilograms
Full Information
NCT ID
NCT03150927
First Posted
April 5, 2017
Last Updated
May 10, 2017
Sponsor
Biowish Technologies, Inc.
Collaborators
University of Wollongong, Mysore Medical College and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03150927
Brief Title
Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biowish Technologies, Inc.
Collaborators
University of Wollongong, Mysore Medical College and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Malnutrition, Growth Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Product will be given to subjects in a capsule form. Participant and participants legal guardians, and care providers will not know if the capsule is a placebo or the Probiotic Microbial Composite™
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic Microbial Composite
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Microbial Composite
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute diarrhea in children ages 3 years to 12 years
Description
Subjects will be assessed as to severity of diarrhea using a standardized measure of diarrheal severity in pediatrics
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Serial assessment of healthy children aged 3 years to 12 years
Description
Subjects will be followed by serial assessment of mid-arm circumference measured in centimeters.
Time Frame
2 years
Title
Serial assessment of healthy children aged 3 years to 12 years
Description
Subjects will be followed by serial assessment of head circumference measured in centimeters.
Time Frame
2 years
Title
Height of healthy children aged 3 years to 12 years
Description
Subjects will be followed by serial assessment of height in centimeters
Time Frame
2 years
Title
Weight of healthy children aged 3 years to 12 years
Description
Subjects will be followed by serial assessment of weight in kilograms
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JoElla Barnes
Phone
+1 312 402 1669
Email
jbarnes@biowishtech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard S Carpenter
Phone
+1 513 680 8868
Email
rcarpenter@biowishtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mudassir A Khan, Ph.D.
Organizational Affiliation
Department of Community Medicine/Public Health Mysore Medical College & Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amit Kapur, MBBS
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard S Carpenter, PhD
Organizational Affiliation
Biowish Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mysore Medical College and Research Institute
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570 001
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mudassir A Khan, PhD
Phone
+91 821 2520512
Email
mudkhan@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
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