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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Immune Status Questionnaire (ISQ Score)
研究概览
简要总结
Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut flora. Probiotics are considered generally safe to consume. They offer numerous health benefits, including digestive and immune health. Improved digestive health is linked to a more efficient absorption of important nutrients from our diet.
Bacillus coagulans is a type of good bacteria, called a probiotic. It produces lactic acid, but isn’t the same thing as Lactobacillus, another type of probiotic. It is one of the most promising probiotics.
The sponsor have developed the probiotic strain called ProBCPlus for the management of immunomodulatory effects and this study aims to evaluate the effect of a Bacillus coagulans-based product on immunomodulation and stress levels in apparently healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
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 including the potential risks and side effects.
- •5.Subjects who are willing to complete all study procedures including study related questionnaires and comply with study requirements.
- •6.Subjects who have given voluntary, written, informed consent to participate in 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 6.Subjects suffering from Abnormal blood pressure 7.Subjects who are allergic to ingredients of the study product 8.Subjects who are using any other pre/pro/symbiotic product.
- •9.Subjects who are Smoker or alcoholic 10.Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
结局指标
主要结局
1. Immune Status Questionnaire (ISQ Score)
时间窗: Day1, Week 4 and week 8
2. Perceived Stress Scale - 10 (PSS -10)
时间窗: Day1, Week 4 and week 8
Differences in hematological parameters (complete blood cell count, lipid profile, kidney and liver function parameters) between the intervention group and the placebo group over the study period.
时间窗: Day1, Week 4 and week 8
次要结局
- •Differences in haematological parameters between the intervention group and the placebo group over the study period(Day1, Week 4 and week 8)