The Use of High Bile-Binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations: A Novel Intervention for Children at Risk for Aspiration-Associated Complications (Aim 2)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Gastric bile acid concentration
研究概览
简要总结
Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria
- •receive at least 80% of their nutritional needs via gastrostomy
- •receive blenderized feeds or will start receiving blenderized feeds
- •have no known allergies to ingredients in blenderized feeds;
- •receive their bolus feeds within 30 minutes or less
- •can receive their feeds by syringe push
排除标准
- •have undergone anti-reflux surgery
- •receive post-pyloric feeds
- •are allergic to any component of the administered diets
- •cannot receive their gastrostomy feeds over 30 minutes
- •require a feeding pump for feed administration (as the H-BBB is too thick for pump administration).
- •Pediatric patients ages 5 to 21 in the observational arm Inclusion
- •receive at least 80% of their nutritional needs via gastrostomy
- •are taking an amino acid formula
- •have not undergone antireflux surgery Exclusion
- •have undergone anti-reflux surgery
- •receive post-pyloric feeds
- •are not receiving an amino acid-based formula.
研究组 & 干预措施
Low bile binding then high bile binding blenderized diets
2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets
干预措施: High bile acid binding blenderized diet (Drug)
Low bile binding then high bile binding blenderized diets
2 weeks of low bile binding then 2 weeks of high bile binding blenderized diets
干预措施: Low bile acid binding blenderized diet (Drug)
High bile binding then low bile binding blenderized diets
2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets
干预措施: Low bile acid binding blenderized diet (Drug)
High bile binding then low bile binding blenderized diets
2 weeks of high bile binding then 2 weeks of low bile binding blenderized diets
干预措施: High bile acid binding blenderized diet (Drug)
结局指标
主要结局
Gastric bile acid concentration
时间窗: after 2 weeks on each of 2 diets (cross-over design)
differences in total gastric bile acid concentrations at the end of each diet period
次要结局
- Gastric bile acid concentration(after 2 weeks on each of 2 diets (cross-over design))
- Symptom scores(after 2 weeks on each of 2 diets (cross-over design))
- Salivary and stool bile acid concentrations(after 2 weeks on each of 2 diets (cross-over design))
- Serum complement 4 (C4)(after 2 weeks on each of 2 diets (cross-over design))
- gastric, salivary, and stool bile acid(after 2 weeks on each of 2 diets (cross-over design))
研究者
Rachel Rosen
Director, Aerodigestive Center
Boston Children's Hospital