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

NCT03150927 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-05-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Wollongong

    collaborator OTHER

  • Mysore Medical College and Research Institute

    collaborator OTHER

  • Biowish Technologies, Inc.

    lead OTHER

Principal Investigators

  • Mudassir A Khan, Ph.D. · Department of Community Medicine/Public Health Mysore Medical College & Research Institute

  • Amit Kapur, MBBS · Prince of Wales Hospital

  • Richard S Carpenter, PhD · Biowish Technologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-09-30
Completion
2019-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150927 on ClinicalTrials.gov