A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of lactobacillales
研究概览
简要总结
The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
详细描述
The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 5 years old receiving transplant (autologous or allogeneic)
- •Parents must give informed consent
排除标准
- •Failure to meet inclusion criteria
研究组 & 干预措施
Enteral Donor Breastmilk
- Donor milk will be pasteurized prior to use.
- Given orally or by nasogastric (NG) or nasojejunal (NJ) tube.
- Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk.
- It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance.
干预措施: Breastmilk (Dietary Supplement)
Control
• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.
结局指标
主要结局
Percentage of lactobacillales
时间窗: 21 days after transplant
Bar chart to indicate percentage of lactobacillales in stool samples.
次要结局
- Incidence of bacteremia(though day 14 post transplant)
- Pro-inflammatory cytokine level(weekly during study course; up to approximately one year)
- Incidence of graft versus host disease (GVHD)(through study course; approximately one year)