Immune Surveillance
Conditions
Brief 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.
Detailed 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 used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.
Interventions
DIETARY_SUPPLEMENTProbiotic Agent
Bacillus coagulans JBI-YZ6.3 (BC4U)
Sponsors
Jeneil Biotech Inc.
Natural Immune Systems Inc
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Placebo-controlled, escalating dose, cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 phone use, during clinic visits.
Exclusion criteria
* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); * Taking anti-inflammatory medications on a daily basis; * Currently experiencing intense stressful events/ life changes; * Currently in intensive athletic training (such as marathon runners); * Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel; * An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); * Unwilling to maintain a constant intake of supplements over the duration of the study; * Anxiety about having blood drawn; * Pregnant, nursing, or trying to become pregnant; * Known food allergies related to ingredients in active test product or placebo.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune communication | 3 hours | Changes in serum cytokine levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune surveillance and alertness | 3 hours | Changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation status following consumption: Numbers of CD3- CD56+ NK cells in blood Numbers of CD3+ CD56+ NKT cells in blood Numbers of CD3+ CD56- T cells in blood Numbers of cells positive for CD25 Numbers of cells positive for CD69 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune responsiveness | 3 hours | Ex vivo immune challenges, documenting the capabilities of anti-bacterial and anti-viral immune responses: Cytokine levels in 24-hour culture supernatants of ex vivo immune cell cultures in unchallenged cultures Cytokine levels in 24-hour culture supernatants of ex vivo immune cell cultures in lipopolysaccharide-inflamed cultures Cytokine levels in 24-hour culture supernatants of ex vivo immune cell cultures in Poly I:C challenged cultures |
Countries
United States
Outcome results
None listed