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临床试验/CTRI/2018/01/011186
CTRI/2018/01/011186进行中（未招募）4 期

An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 on Antibiotic associated Diarrhoea In Humans

Synergia Life Sciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月22日最近更新:
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适应症

试验速览

阶段
4 期
状态
进行中（未招募）
入组人数
60
试验地点
1
主要终点
To evaluate the role of Probiotic- Bacillus subtilis HU58 in Antibiotic associated Diarrhoea in Humans in comparison to placebo
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The current study is formulated in order to evaluate the effect of supplementation of Bacillus subtilis HU58 Probiotics on Antibiotic associated Diarrhea in humans in comparison with placebo.

N = 60

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 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

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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