Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW 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. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.
详细描述
The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 2 Months（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
Saccharomyces boulardii
Saccharomyces boulardii 5 million unit/day for 3 months
干预措施: Saccharomyces boulardii (Drug)
control
Placebo- for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
时间窗: up to 6 months
次要结局
- Effect of Saccharomyces boulardii on weight gain(up to 6 months)
- Effect of Saccharomyces boulardii on length of hospital stay(up to 6 months)
- Effect of Saccharomyces boulardii on mortality(up to 6 months)
- Effect of Saccharomyces boulardii on culture proved sepsis(6 months)