A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effect of a Bacillus coagulans-based product on immunomodulation and stress levels.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect on the systemic and adaptive immune system will be measured by change in ISQ score from baseline to eight weeks of treatment between the intervention group and the placebo group
研究概览
简要总结
Probiotic: Probioticsare live microorganisms promoted with claims that they provide health benefitswhen consumed, generally by improving or restoring the gut flora. Probioticsare considered generally safe to consume. Bacillus coagulans isa type of good bacteria, called a probiotic. It produces lactic acid, but isn’tthe same thing as Lactobacillus, another type of probiotic. It is one ofthe most promising probiotics. The sponsor have developed theprobiotic strain called ProBCPlus for the management of immunomodulatory effects andthis study aims to evaluate the effect of a Bacilluscoagulans-based product on immunomodulation and stress levels in apparentlyhealthy subjects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male/female of age 18-65 years.
- •2.FBG (≤ 126 mg/dl).
- •3.Normal blood parameters (Hb ≥ 10 g/dl).
- •4.Subjects who understand the nature and purpose of the study.
排除标准
- •1.Women who are pregnant or Lactating.
- •2.Subjects who are taking Antibiotic treatment 3.Subjects suffering from Gastrointestinal disease 4.Subjects suffering from Diabetes 5.Subjects suffering from Chronic/iatrogenic immunodeficiency.
结局指标
主要结局
Effect on the systemic and adaptive immune system will be measured by change in ISQ score from baseline to eight weeks of treatment between the intervention group and the placebo group
时间窗: 8 weeks
次要结局
- 1.Differences in hematological parameters such as CBC in-between the 2 groups over the study period.(2.Differences in Immune parameters such as Kidney Function, Liver Function IgG, IgM, IgA,Lipid Profile in-between the 2 groups over the study period)