CTRI/2018/06/014439进行中（未招募）4 期
An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 on Antibiotic associated Diarrhoea in Humans
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placebo
研究概览
简要总结
The current study is formulated in order to evaluate the effect of supplementation of Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC209 on Antibiotic associated Diarrhea in humans in comparison with placebo.
N = 75
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
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.Male and female aged 18 to
- •2.Stable ECG.
- •3.Willing to give informed consent.
排除标准
- •1.Sero positive patients.
- •2.Pregnancy.
- •3.Subjects who are on other Probiotics or prebiotics.
- •4.Subjects who are addicted to tobacco, alcohol.
- •5.Subjects who are on any other medication than prescribed oral antibiotics.
结局指标
主要结局
To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placebo
时间窗: 15 days
次要结局
- Safety and tolerability; clinical variables(15 days)
研究者
研究点 (1)
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