Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules (Probiomega)
Recruitment status was: Recruiting
|Signs and Symptoms, Digestive||Dietary Supplement: probiotic plus fish oil capsule Dietary Supplement: Fish oil capsule|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults|
- Fecal probiotic (KE-99) level [ Time Frame: Fecal samples collected at baseline and after 7 days of treatment, during each treatment arm. ]KE-99 probiotic levels will be measured from fecal samples at baseline and compared to levels measured after 7 days of treatment to determine if live KE-99 bacteria survive transit through the gastrointestinal tract.
- SF-36v2 [ Time Frame: At baseline and after 7 days of each treatment arm. ]SF-36v2 - is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Results will be compared between and within groups.
- GI questionnaire [ Time Frame: At baseline and after 7 days of each treatment arm. ]GI Questionnaire - a six-part questionnaire regarding general well-being and gastrointestinal symptoms will be administered, with results being compared between and within groups.
- Tolerability Questionnaire [ Time Frame: After 7 days of each treatment arm. ]Tolerability of the study products will be assessed at the end of each seven-day supplementation period (at visits 3 and 5).
- qPCR Fecal Microbiota Analyses [ Time Frame: Measuerd at baseline (Day 0) and after 7 days, of each treatment arm. ]Reverse transcription-quantitative PCR (RT-qPCR) will be performed at baseline (Day 0) and after 7 days of treatment, to compare human intestinal microbiota after treatment to baseline.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Lactobacillus casei in fish oil capsule
Dietary Supplement: probiotic plus fish oil capsule
Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.
Other Name: Probiomega
Placebo Comparator: Placebo
Fish oil capsule
Dietary Supplement: Fish oil capsule
Fish oil capsule, T.I.D., for seven (7) days
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464814
|Contact: Samantha Feldman, MS, RD||305-722-0970 ext email@example.com|
|United States, Florida|
|Broward Research Group||Recruiting|
|Pembroke Pines, Florida, United States, 33026|
|Contact: Samantha Feldman, MS, RD 305-722-0970 ext 3311 firstname.lastname@example.org|
|Principal Investigator:||David Seiden, MD||Broward Research Group|