NCT06913621尚未招募不适用
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 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 主要终点
- total hospitalization and emergency room visits rates
研究概览
简要总结
Using a longitudinal cohort design, we will compare the impact of a high BA-binding blenderized diet compared to a low BA-binding blenderized diet and an amino acid-based formula, on gastrointestinal and pulmonary hospitalization and emergency room visit rates over six months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 via gastrostomy
- •receive an International Dysphagia Diet Standardization Initiative level 4 commercial blend, home blend or amino acid-based formula
- •receive their bolus feeds within 30 minutes or less.
排除标准
- •have undergone anti-reflux surger
- •receive post-pyloric feeds
- •receive regular daily prophylactic antibiotics.
研究组 & 干预措施
amino acid-based formula
干预措施: amino acid formula (Drug)
Low bile binding blenderized diet
干预措施: low bile acid binding blenderized diet (Drug)
High bile binding blenderized diet
干预措施: high bile acid binding blenderized diet (Drug)
结局指标
主要结局
total hospitalization and emergency room visits rates
时间窗: 6 months
total hospitalization and emergency room visits rates between participants receiving H-BBB and those receiving L-BBB or an amino acid-based formula
次要结局
- differences in pulmonary, gastrointestinal or ICU admission rates(6 months)
- differences in metagenomic patterns between diets(6 months)
- differences in bile acid concentrations(6 months)
- correlations between microbial abundance and diversity and hospitalization and emergency room visit rates(6 months)
- correlations between admission rates by diet type and short chain fatty acid concentrations(6 months)
研究者
Rachel Rosen
Director, Aerodigestive Center
Boston Children's Hospital
相似试验
已完成
不适用
Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic SyndromeMetabolic SyndromeCardiovascular DiseaseNCT00937638Penn State University63
已完成
不适用
Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the ElderlyDysphagiaNCT04901182Mahidol University63
已完成
不适用
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by RacePre DiabetesObesityNCT03771261Duke University99
已完成
不适用
The Impact of a High-protein Diet on Energy Metabolism in Healthy MenDietary ModificationNCT03565510University of Alberta27
已完成
不适用
Diet Modulation of Bacterial Sulfur and Bile Acid Metabolism and Colon Cancer RiskColorectal CancerNCT03550885University of Illinois at Chicago15