Clinical trial NCT03150927: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Malnutrition
Growth Arrest
Lead sponsor: Biowish Technologies, Inc.
Sponsor class: OTHER
Collaborators: name: University of Wollongong
name: Mysore Medical College and Research Institute
First posted: 2017-05-12
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Acute diarrhea in children ages 3 years to 12 years
timeFrame: 24 weeks
Secondary outcomes:
measure: Serial assessment of healthy children aged 3 years to 12 years
timeFrame: 2 years
measure: Serial assessment of healthy children aged 3 years to 12 years
timeFrame: 2 years
measure: Height of healthy children aged 3 years to 12 years
timeFrame: 2 years
measure: Weight of healthy children aged 3 years to 12 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Mysore
country: India
facility: Mysore Medical College and Research Institute
state: Karnataka
Study officials:
affiliation: Department of Community Medicine/Public Health Mysore Medical College & Research Institute
name: Mudassir A Khan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital
name: Amit Kapur, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Biowish Technologies, Inc.
name: Richard S Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
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