Acute Immune Modulation by Probiotic Strain Bacillus Coagulans JBI-YZ6.3 (BC4U)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Immune communication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group A
Crossover study: Participants will be consuming placebo on the first clinic visit, a low dose of the probiotic on the second clinic visit, a medium dose of the probiotic on the third clinic visit, and a high dose of the probiotic on the fourth clinic visit. Each clinic visit is separated by at least 1 week wash-out period.
干预措施: Probiotic Agent (Dietary Supplement)
结局指标
主要结局
Immune communication
时间窗: 3 hours
Changes in serum cytokine levels
次要结局
- Immune surveillance and alertness(3 hours)