Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Z-scores of weight for age
研究概览
简要总结
To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.
详细描述
This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meets the diagnostic criteria of cholestasis
- •Artificial feeding (formula feeders)
- •Age ≤6 months
- •The course of cholestasis was > 1 month
- •Informed consent of the guardian
排除标准
- •There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
- •Cholestasis with ascites and diarrhea
- •In patients with oxidative impairment of medium chain fatty acids
结局指标
主要结局
Z-scores of weight for age
时间窗: "from enrollment to the 4 weekend(28 days)"
The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.
次要结局
未报告次要终点