Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Stool Microbiome
研究概览
简要总结
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.
Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born less than 29 weeks gestation and <1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.
排除标准
- •Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.
研究组 & 干预措施
Probiotic
Florababy probiotic (0.5g per day) will be started at or after 72 hours of life and will be administered in 1ml sterile water prior to feed.
干预措施: Florababy (Dietary Supplement)
Control
Standard of care arm
结局指标
主要结局
Stool Microbiome
时间窗: 4 weeks
difference in stool microbiome after Florababy or no drug administration
次要结局
- Stool Microbiome(2 weeks)
- Full Feeds(4-6 weeks)
- Feeding intolerance(4-6 weeks)
研究者
Belal Alshaikh
Neonatologist
University of Calgary