Acute Immune Modulation by Probiotic Strain Bacillus Coagulans JBI-YZ6.3 (BC4U)
Natural Immune Systems Inc
Summary
Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.
Description
Clinical proof-of-concept study comparing the acute immune effects of 3 doses of a probiotic compared to a placebo. The probiotic strain is characterized as Bacillus coagulans JBI-YZ6.3 (BC4U). 24 subjects will participate in a placebo-controlled, escalating dose, cross-over study design, wherein they will be taking placebo, dose 1, dose 2, and dose 3, each separated by a 1-week washout period. Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration. A series of immune panels will be use…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy adults; * Age 18-75 years (inclusive); * Veins easy to see in one or both arms (to allow for the multiple blood draws); * Willing to comply with study procedures, including: * Maintaining a consistent diet and lifestyle routine throughout the study, * Consistent habit of bland breakfasts on days of clinic visits, * Abstaining from exercising and nutritional supplements on the morning of a study visit, * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; * Abstaining from music, candy, gum, computer/cell p…
Interventions
- Dietary SupplementProbiotic Agent
Bacillus coagulans JBI-YZ6.3 (BC4U)
- Dietary SupplementProbiotic Agent
An escalating dose cross-over design: Participants are fed 0 mg, 100 mg, 200 mg, and 400 mg on different clinic visits.
Location
- NIS LabsKlamath Falls, Oregon