Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
NCT ID: NCT03150927
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2017-09-30
2019-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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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).
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
Placebo is a mixture of inactive ingredients found in Probiotic Microbial Composite. These ingredients are FDA approved food grade materials, 100% natural and palatable.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Outpatient setting: healthy children aged 3 years to 12 years
Exclusion Criteria
* 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.
3 Years
12 Years
ALL
Yes
Sponsors
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University of Wollongong
OTHER
Mysore Medical College and Research Institute
OTHER
Biowish Technologies, Inc.
OTHER
Responsible Party
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Principal Investigators
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Mudassir A Khan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Community Medicine/Public Health Mysore Medical College & Research Institute
Amit Kapur, MBBS
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Richard S Carpenter, PhD
Role: PRINCIPAL_INVESTIGATOR
Biowish Technologies, Inc.
Locations
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Mysore Medical College and Research Institute
Mysore, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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BWT-20150720-001
Identifier Type: -
Identifier Source: org_study_id
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