NCT01411761Unknown4 期
Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia
Zekai Tahir Burak Women's Health Research and Education Hospital2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2011年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
研究概览
简要总结
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on 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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 15 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very low birth weight infants
排除标准
- •chromosomal anomalies
研究组 & 干预措施
Saccharomyces boulardii
Experimental
study group
干预措施: Reflor (Dietary Supplement)
placebo
Placebo Comparator
serum physiologic
干预措施: serum physiologic (Other)
结局指标
主要结局
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
时间窗: 6 months
次要结局
- long term effect of S.boulardii on neurodevelopmental outcome(6 months)
研究者
研究点 (2)
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