Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intestinal flora
研究概览
简要总结
Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment from microbial colonization. As the effects of diet, intestinal flora is rapidly changed. Preterm children significantly delay in the establishment of normal flora,during hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay, combat disease and other factors. In this study, hospitalized preterm children for the study, the prospective randomized double-blind controlled study, to find oral intestinal bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution, and further show intestinal bacteria in premature children case group.
详细描述
Preterm infants are at high risk of deeding intolerance especially low birth weight infants, Whether oral triple viable Bifidobacterium and early Micro-feeding may improve the symptoms of feeding intolerance.
84 preterm infants BW(birth weight) less than 2.5kg,entered neonatal intensive care unit(NICU) less than 24 hours and meet the Inclusion Criteria of this study will be Randomly divided into three groups, control group、 treatment group1 (Triple viable Bifidobacterium 0.5g bid po)、treatment group2 （Triple viable Bifidobacterium 0.5g bid po and early micro-feeding）. treatment period for more than 1 week. For three groups, feeding symptoms,the traits and frequency of stool of 3 days,1 weeks,2 weeks.And the stool flora measured by PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm with birth weight <2.5kg
排除标准
- •Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation
研究组 & 干预措施
a control group
a control group : the same dose of luke warm water
干预措施: a control group (Drug)
treatment group
treatment group: viable Bifidobacterium 0.5 bid po
干预措施: a probiotic-supplemented group (Drug)
结局指标
主要结局
Intestinal flora
时间窗: up to one week
measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants
次要结局
- Feeding intolerance(up to one week)
研究者
Wang Hua
Director of pediatric
Kunshan First People's Hospital Affiliated to Jiangsu University