Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Intestinal microbiome
研究概览
简要总结
Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Surgical stress is known to cause disruption of the gut barrier and increase intestinal permeability and bacterial translocation. This process triggers exaggerated immune responses that lead to inflammation and sometimes infectious complications. Post-operative use of antibiotics has been shown to potentiate the growth of pathogenic bacterial species Adults with abdominal surgery who received post-op probiotics reported a significant reduction in surgical site infection, urinary tract infection, and combined infection. Currently, probiotics used only in the non-surgical population of infants.
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing intestinal surgery.
详细描述
Research Objectives/Question:
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing gastrointestinal surgery.
Primary question:
Diversity and abundance of stool microbiome at after 1 and 3 weeks of initiation of probiotics
Secondary outcomes:
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 born between 23 - 41 weeks of gestation
- •Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
- •Ready to start enteral feeding
排除标准
- •Infants with major congenital anomalies excluding gastrointestinal tract
- •Palliative care patients
- •Septic babies with positive blood, CSF or urine culture
结局指标
主要结局
Intestinal microbiome
时间窗: 3 weeks after surgury
Stool microbiome
次要结局
- Length of hospital stay(6 months)
研究者
Belal Alshaikh
Clinical Associate Professor, Department of Pediatrics
University of Calgary
