A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Upper GI symptoms
研究概览
简要总结
The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 1 year
- •>90% of total calories via G-tube for > 6 months
- •G-tube diameter ≥ 14 French
- •moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score > 2
- •anticipated stable GI-related medications for the duration of the study.
排除标准
- •cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
- •untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
- •Nissen fundoplication
- •use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
- •allergy or intolerance to any component of the study diet
- •inability to tolerate bolus gastric feeds.
研究组 & 干预措施
Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Extremely thick blenderized tube feed (Other)
Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Mildly thick blenderized tube feed (Other)
Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Extremely thick blenderized tube feed (Other)
Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Mildly thick blenderized tube feed (Other)
Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Extremely thick blenderized tube feed (Other)
Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Mildly thick blenderized tube feed (Other)
Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Extremely thick blenderized tube feed (Other)
Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
干预措施: Mildly thick blenderized tube feed (Other)
结局指标
主要结局
Upper GI symptoms
时间窗: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds
次要结局
- urine output adequacy(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- GI medication use(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Weight for height/body mass index (BMI)(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Health care utilization(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- number of patients with unplanned G-tube exchange(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Weight(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Pulmonary symptoms(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Height(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- rate of respiratory suctioning per day(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- need for antibiotics for pneumonitis(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
- Gastrointestinal symptoms(8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design))
研究者
Bridget Hron
Staff Physician
Boston Children's Hospital