NCT01463943撤回3 期
"An Open-Label, Non-Inferiority, Phase III Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® (S. Boulardii - Merck) in the Prevention of Antibiotic-Associated Diarrhea."
Eurofarma Laboratorios S.A.17 个研究点 分布在 1 个国家开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 17
- 主要终点
- frequency of diarrhea in subjects using antibiotics
研究概览
简要总结
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICF signature;
- •The subject must agree to follow the instructions and to perform study procedures and visits;
- •Male and female subjects between 18 and 65 years old;
- •Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:
排除标准
- •Generalized infection or bacteremia;
- •Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome);
- •Documented chronic diarrhea;
- •Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral);
- •Immunodeficiency (radiotherapy or chemotherapy);
- •Use of food with probiotic properties in the last 10 days;
结局指标
主要结局
frequency of diarrhea in subjects using antibiotics
次要结局
- Frequency of diarrhea by severity
研究者
研究点 (17)
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