A Pilot 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
- 11
- 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 micobiota in children receiving human milk, with those receiving conventional feeding.
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
- 年龄范围
- — 至 5 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 breast 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)
结局指标
主要结局
Percentage of lactobacillales
时间窗: 21 days after transplant
Bar charts to indicate types and percentage of bacteria in stool samples - will quantify the bacterial diversity using the Shannon index and bacterial chaos using the Bray-Curtis time index.
次要结局
- Levels of pro-inflammatory cytokines(Weekly during study course; up to approximately one year)
- Incidence of graft versus host disease (GVHD)(through study course; approximately one year)
- Incidence of bacteremia(through day 14 post transplant)