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临床试验/NCT01531179
NCT01531179已完成3 期

Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis 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 400 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Lactobacillus reuteri 100 million CFU/day for 3 months

干预措施: Lactobacillus reuteri (Drug)

Control

Placebo Comparator

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

发起方
Zekai Tahir Burak Women's Health Research and Education Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Yekta

Principal Investigator

Zekai Tahir Burak Women's Health Research and Education Hospital

研究点 (1)

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