A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein absorption.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2.Short Health Scale for GI symptoms (SHS-GI) for Bacillus coagulans-based product on protein absorption
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 live bacteria and yeasts that are good us especially for the digestive system. Probiotics are considered generally safe to consume. Probiotics had a positive significant effect across all eight gastrointestinal diseases with a relative risk of 0.58 (95% (CI) 0.51–0.65).Six of the eight diseases: Pouchitis, Infectious diarrhoea, Irritable Bowel Syndrome, Helicobacter pylori Clostridium difficile Disease, and Antibiotic Associated Diarrhoea, showed positive significant effects. Understanding the above facts, the sponsor has developed the probiotic strain of BC, called as ProBCPlus. The aim of the current clinical trial is to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract in healthy human volunteers.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject has provided written and dated informed consent to participate in the study.
- •2.Subject is willing and able to comply with the protocol.
- •3.Healthy male/female of age 18-60 years (both inclusive).
- •4.Subject is in good health as determined by Principal Investigator.
排除标准
- •1.Subject on protein and/ or probiotic rich diet.
- •2.Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrolment.
- •3.Subject has a history of alcohol or other drug abuse in the past year 4.Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
结局指标
主要结局
2.Short Health Scale for GI symptoms (SHS-GI) for Bacillus coagulans-based product on protein absorption
时间窗: 8 weeks
3.Food frequency questionnaire (FFQs)
时间窗: 8 weeks
1.Change in urine urea nitrogen for Bacillus coagulans-based product on protein absorption
时间窗: 8 weeks
次要结局
- Safety of Bacillus coagulans-based product on protein absorption(8 Weeks)