A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Short Form-8 Health Survey (SF-8) at 28 Days
研究概览
简要总结
This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cirrhosis - must meet one of the following criteria:
- •liver biopsy, OR
- •history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
- •2 of the following 4 criteria:
- •Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- •Fibroscan liver stiffness score >13 Kilopascal (kPa)
- •Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0
- •CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
排除标准
- •Non-English speaking
- •Pregnancy (self-reported)
- •Unable or unwilling to provide consent
- •History of liver transplant
- •Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder
- •History of prior lactulose use or HE within 6 months
- •Metastatic solid malignancy or blood malignancy
- •Hemoglobin A1C > 12 (within past year)
研究组 & 干预措施
Lactulose
干预措施: Lactulose (Drug)
结局指标
主要结局
Short Form-8 Health Survey (SF-8) at 28 Days
时间窗: 28 days
The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).
次要结局
- Animal Naming Test (ANT)(28 days)
- Participants Who Fell(28 days)
- Daily Bowel Movements(28 days)
- Change in Overall Sleep Quality(Change between baseline (day 0) and 28 days)
- Regular Daily Activity Impairment(28 days)
研究者
Elliot B. Tapper
Assistant Professor of Internal Medicine
University of Michigan