Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Time to reach full feeds
研究概览
简要总结
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.
The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.
详细描述
The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live
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)
盲法说明
Administration of placebo
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
排除标准
- •Chromosomal anomalies.
- •Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- •Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- •Parental refusal
- •Prior enrollment into a conflicting clinical trial
研究组 & 干预措施
Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.
干预措施: Placebo (Other)
probiotic group
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
干预措施: Lactobacillus reuteri (Dietary Supplement)
结局指标
主要结局
Time to reach full feeds
时间窗: First 40 days after birth
Days to reach full feeds from the day feeds are started
次要结局
- Intestinal colonization(0-6 months after birth)
- Intestinal immunological response(0-6 months)
研究者
Teresa del Moral
Associate Professor
University of Miami