NCT01464814

Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules

A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nutrition 21, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic plus fish oil capsule	Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.
DIETARY_SUPPLEMENT	Fish oil capsule	Fish oil capsule, T.I.D., for seven (7) days

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-11-04
• Last updated: 2011-11-16

Locations

1 site across 1 country: United States