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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03150927
• Other study ID #: BWT-20150720-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 5, 2017
• Last updated: May 10, 2017
• Start date: September 2017
• Est. completion date: September 2019

Study information

• Verified date: May 2017
• Source: Biowish Technologies, Inc.
• Contact: JoElla Barnes
• Phone: +1 312 402 1669
• Email: jbarnes[@]biowishtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Growth Arrest
• Malnutrition
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Mysore Medical College and Research Institute	Mysore	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Biowish Technologies, Inc.	Mysore Medical College and Research Institute, University of Wollongong

Country where clinical trial is conducted

India, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	Serial assessment of healthy children aged 3 years to 12 years	Subjects will be followed by serial assessment of head circumference measured in centimeters.	2 years
Secondary	Height of healthy children aged 3 years to 12 years	Subjects will be followed by serial assessment of height in centimeters	2 years
Secondary	Weight of healthy children aged 3 years to 12 years	Subjects will be followed by serial assessment of weight in kilograms	2 years