NCT01605747终止2 期
A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Infectious outcome
研究概览
简要总结
The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute burn injury
- •consented within 10 days of injury
- •feeding tube present-
排除标准
- •GI disorder prior to burn
- •milk allergy or insensitivity
- •non-burned
研究组 & 干预措施
Culturelle
Experimental
干预措施: Culturelle (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Infectious outcome
时间窗: 3 years
Record incidence of infection between the experimental and placebo groups.
次要结局
- Clinical outcome(3 years)
研究者
Michele Gottschlich
Director, Nutrition Services
Shriners Hospitals for Children
研究点 (2)
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