NCT01411748Unknown4 期
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Zekai Tahir Burak Women's Health Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
研究概览
简要总结
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight infants < 1500 gr
排除标准
- •Genetic anomalies
- •Not willing to participate
- •Allergy to S. boulardii components
研究组 & 干预措施
S. boulardii
Experimental
The patients in this group will be given 5 million unit/day S. boulardii until discharge.
干预措施: Reflor (Dietary Supplement)
nystatin
Active Comparator
干预措施: mikostatin (Drug)
结局指标
主要结局
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
时间窗: 6 months
次要结局
- Effect of S. boulardii on sepsis(6 months)
研究者
研究点 (1)
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