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 1)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastric bile acid concentration
研究概览
简要总结
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe.
Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •receive at least 80% of their nutritional needs by gastrostomy
- •receive either an amino acid-based formula, an International Dysphagia Diet Standardization Initiative level 4 commercial blend, or a home blend
- •can receive bolus feeds of 240 cc within 30 minutes or less
排除标准
- •have received a fundoplication
- •receive post-pyloric feeds
- •require medication/flush administration during the four-hour study period
- •are allergic to any component of the study diets.
- •To participate in this study, if patients are taking acid suppression or motility medications (e.g., erythromycin, azithromycin, prucalopride), they will need to stop these at least 72 hours prior to participation in this aim.
研究组 & 干预措施
low bile acid binding blenderized diet (e.g., real food blends)
干预措施: low bile acid binding blenderized diet (e.g. Kate Farms) (Drug)
high bile acid binding blenderized diet (proprietary)
干预措施: high bile acid binding blenderized diet (Drug)
amino acid-based formula (e.g., elecare, neocate)
干预措施: amino acid based formula (e.g. Elecare Jr) (Drug)
结局指标
主要结局
Gastric bile acid concentration
时间窗: 4 hours
Mean difference in gastric bile acid concentrations between start of feed and four hours following feed
次要结局
- correlations between C13 excretion rates and gastric and salivary bile acid concentrations(Baseline to 1, 2, 3 and 4 hours post-prandial)
- Gastric bile acid concentration(1, 2 and 3 hours)
- Correlations between gastric bile acid and gastroesophageal reflux Likert scale(Baseline to 1, 2, 3 and 4 hours post-prandial)
- Correlation of symptom scores with gastric and salivary bile acid concentration(baseline)
- Correlation of gastric and salivary bile acid concentrations(0, 1, 2, 3 and 4 hours post-prandial)
研究者
Rachel Rosen
Director, Aerodigestive Center
Boston Children's Hospital