Signs and Symptoms, Digestive Clinical Trial
Official title:
A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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