CTRI/2022/12/048573尚未招募Unknown
A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract
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
- 1.Primary outcome measure(s) will be change from baseline in Creatine Kinase and CRP
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 for us especially for the digestive system. Probiotics are considered generally safe to consume.
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
- 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 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.
- •4.Subject is in good health as determined by a health history questionnaire.
排除标准
- •1.Subject has a known allergy or sensitivity to any ingredient in the test product.
- •2.Subject on protein and/ or probiotic rich diet.
- •3.Subject has a history of alcohol or other drug abuse in the past year.
结局指标
主要结局
1.Primary outcome measure(s) will be change from baseline in Creatine Kinase and CRP
时间窗: 8 weeks
Score (measured after exercise bout) at day 1, week 4 and week8.
时间窗: 8 weeks
次要结局
- Improvement in the symptoms and signs of protein absorption and digestion, based on evaluation on Creatine Kinase and CRP and Pain VAS for muscle soreness, at the end of therapy.(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Controlled parallel-group clinical study to assess the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract.CTRI/2020/07/026454Abode Biotec India Private Limited30
尚未招募
Unknown
To evaluate the effects of a Bacillus coagulans-based product on protein absorption.CTRI/2023/04/051660Abode Biotec India Private Limited30
尚未招募
Unknown
A clinical study to assess the effect of a Bacillus coagulans-based product on immunomodulation and stress levelsCTRI/2023/01/048720Abode Biotec India Private Limited50
已完成
不适用
Study to Explore the Effects of Probiotics on Endotoxin Levels in Type 2 Diabetes Mellitus PatientsDiabetes Mellitus Type 2NCT01765517King Saud University83
已完成
不适用
Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative ColitisUlcerative ColitisNCT00951548VSL Pharmaceuticals144