Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
研究概览
简要总结
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
详细描述
Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17
- •Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy
- •Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally.
- •Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)
排除标准
- •Patients receiving IV antibiotics within the previous 72h.
- •Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease)
- •Malnourished (as defined by Weight/Height Z-score (WHZ) <-2)
结局指标
主要结局
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
时间窗: Total study duration 14 days
Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
时间窗: Total study duration14 days
Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.
次要结局
- Tolerance: Reported Episodes of Abdominal Distension and Emesis(14 days)
研究者
Christopher Duggan
Professor of Pediatrics
Boston Children's Hospital