Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
研究概览
简要总结
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
详细描述
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
排除标准
- •patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
- •patients with known hearing or vision difficulties.
- •those patients who do not speak English will be excluded.
研究组 & 干预措施
Lactulose
3 months of Lactulose therapy based on pt. weight
干预措施: Lactulose (Drug)
placebo
1.5 ml/kg day po of sugar water placebo for three months
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
时间窗: baseline
failure of one cognitive function test indicates presence of MHE
次要结局
- Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function(before and after each treatment period)
- Health Related Quality of Life (HRQOL)(baseline)