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

NCT03150927 | Unknown DMC

• 1 other identifier: BWT-20150720-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Malnutrition; Growth Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Serial assessment of healthy children aged 3 years to 12 years

  2 years

• Serial assessment of healthy children aged 3 years to 12 years

  2 years

• Height of healthy children aged 3 years to 12 years

  2 years

• Weight of healthy children aged 3 years to 12 years

  2 years

Study Arms (2)

Probiotic Microbial Composite

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic Microbial Composite DIETARY_SUPPLEMENT

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.

Probiotic Microbial Composite

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Inpatient setting: Children with age of 3 years to 12 years with acute diarrhea
• Outpatient setting: healthy children aged 3 years to 12 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biowish Technologies, Inc.: lead
• University of Wollongong: collaborator
• Mysore Medical College and Research Institute: collaborator

Study Sites (1)

Mysore Medical College and Research Institute

Mysore, Karnataka, 570 001, India

Location

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MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JoElla Barnes

CONTACT

+1 312 402 1669; jbarnes@biowishtech.com

Richard S Carpenter

CONTACT

+1 513 680 8868; rcarpenter@biowishtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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™
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: May 12, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

IN (1)