A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts
研究概览
简要总结
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.
详细描述
Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants with a birth weight < 1500g
- •admission to NICU at The Nebraska Medical Center
排除标准
- •infants who have congenital anomalies
- •have a diagnosis of a congenital metabolic disease
- •are made a ward of the State or
- •are born to a mother < 19 years of age
研究组 & 干预措施
Multi-strain Probiotic
Multi-strain Probiotic without prebiotics.
干预措施: Multi-strain Probiotic (Dietary Supplement)
Multi-strain Synbiotic
Multi-strain probiotic with prebiotics
干预措施: Multi-strain Probiotic (Dietary Supplement)
结局指标
主要结局
Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts
时间窗: 1,2, 3, 4 and 34 weeks of age
Infants will be given the synbiotic or probiotic supplementation within the first week of life (upon inititation of enteral feedings) until approximately 34 weeks corrected gestational age.
次要结局
- Compare the difference between infants successfully colonized with probiotic organisms (>10^2 colonies on a 10^4-fold dilution plate)to infants not successfully colonized on demographics and selected standard clinical outcomes(1 week of life to NICU discharge)
- Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes.(From birth to NICU discharge (average 36 weeks corrected gestational age))
- Compare infants successfully colonized with probiotic organisms(>10^2 colonies on a 10^4-fold dilution plate) to infants not successfully colonized on stress biomarker levels(day of life 1 to day of life 7)
- Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes(day of life 1 to day of life 7)
- Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes.(6, 16 & 24 months corrected gestational age.)