NCT01143623已完成2 期
Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Incidence of antibiotic-associated diarrhea
研究概览
简要总结
The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 30-70 years
- •initiating antibiotic therapy
- •informed consent
排除标准
- •current diarrhea
- •life threatening illness
- •habitual probiotic use
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Probiotic-2
Active Comparator
干预措施: Probiotic (Dietary Supplement)
Probiotic
Active Comparator
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Incidence of antibiotic-associated diarrhea
时间窗: 5 weeks after antibiotic discontinuation
次要结局
未报告次要终点
研究者
研究点 (1)
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