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Clinical Trial Summary

The purpose of this study is to determine the effects of the probiotic KE-99 Lactobacillus casei when administered with omega-3 fish oil on probiotic viability, fecal make-up and gastrointestinal (GI) health in healthy adults.


Clinical Trial Description

This is a randomized, placebo controlled, crossover clinical trial to determine the effects of KE-99 Lactobacillus casei with omega-3 fish oil, a probiotic purported to promote beneficial effects in gastrointestinal (GI) health. The study will last approximately three weeks with subjects attending a screening visit and four follow-up visits.

The study will involve subjects taking the probiotic product (KE-99 + fish oil)and placebo, each for seven days (as per sponsor guidance), in random order, with a seven day washout in between (as per sponsor guidance). Fecal analyses will be done at the beginning and end of each seven day supplementation period so that the number of live KE-99 in feces can be determined with higher numbers being positive (indicates more live KE-99 survived digestion).

Although the study population will be comprised of generally healthy adults that do not have GI disorders or symptoms, the sponsor hypothesizes that there may be beneficial effects in GI health with the KE-99 + fish oil supplementation. A six item questionnaire will be used to assess changes in GI health (e.g. abdominal pain, bloating and gas) with lower incidence indicating positive effects with regard to GI health. ;


Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01464814
Study type Interventional
Source Nutrition 21, Inc.
Contact Samantha Feldman, MS, RD
Phone 305-722-0970
Email sfeldman@miamiresearch.com
Status Recruiting
Phase N/A
Start date October 2011
Completion date November 2011

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