A Pilot Study of Enteral Donor Human Milk in Young Children With Norovirus Infection of the Gut
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Loose/Unformed/Liquid Stools or Abdominal Cramping
研究概览
简要总结
Human Breast milk in young children with Norovirus Infection
详细描述
The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with at least two stool samples taken at least 7 days apart that are positive for norovirus
- •Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired.
排除标准
- •The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.
研究组 & 干预措施
Donor Breastmilk
Donated human milk is subjected to pasteurization prior to use. Milk consumption is to be overseen by a Registered Dietician. Oral or enteral milk feeding will begin at 180 ml/day and will be advanced as quickly as tolerated to a goal of 360 ml/day for 6 weeks. If symptoms and stool tests for norovirus do not improve after 6 weeks, milk administration may continue for an additional 6 weeks.
干预措施: Donor Breastmilk (Dietary Supplement)
结局指标
主要结局
Loose/Unformed/Liquid Stools or Abdominal Cramping
时间窗: Up to 12 weeks
Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported.
Norovirus
时间窗: Up to 12 weeks
Stool samples will be tested for the presence of norovirus.
次要结局
未报告次要终点