Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Effect of Lactobacillus reuteri 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 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis 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 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight infants < 1500 gr
- •Gestational age < 32 weeks
排除标准
- •Genetic anomalies
- •Short bowel syndrome
- •Not willing to participate
- •Allergy to Lactobacillus reuteri components
研究组 & 干预措施
Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months
干预措施: Lactobacillus reuteri (Drug)
Control
Placebo for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
时间窗: up to 6 months
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.
次要结局
- Effect of Lactobacillus reuteri on culture proved sepsis(up to 6 months)
- Effect of Lactobacillus reuteri on weight gain(up to 6 months)
- Effect of Lactobacillus reuteri on length of hospital stay(up to 6 months)
研究者
Mehmet Yekta
Principal Investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
