NCT01191112已完成3 期
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Stool frequency
研究概览
简要总结
The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant female between 1 and 13 years of age.
- •Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
- •Subject requires enteral tube feeding as sole source of nutrition.
排除标准
- •History of diabetes.
- •Requires artificial ventilation.
- •Requires parenteral nutrition.
- •Subject has intestinal obstruction.
- •Subject is receiving dialysis treatment.
- •Subject has an allergy or intolerance to any ingredient in the study product.
研究组 & 干预措施
Peptide Based enteral formula
Experimental
干预措施: Peptide based enteral formula (Other)
结局指标
主要结局
Stool frequency
时间窗: 14 Days
Frequency and intensity of irritability, vomiting, distension
时间窗: 14 Days
次要结局
- Medication Use(14 days)
- Anthropometrics(14 Days)
- Average Energy Intake(14 Days)
研究者
研究点 (1)
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