NCT02255617已完成1 期
A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Portion of participants with normailzation of ICT or Stroop Test during the study
研究概览
简要总结
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.
详细描述
Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4. HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (age > 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
- •abnormal inhibitory control test, defined as greater than 5 lures.
- •an infectious etiology which may cause HE has been ruled out
排除标准
- •those with tense ascites
- •those who do not provide assent
- •those who are judged to have a life expectancy of less than 3 months,
- •those who had TIPS within 3 months,
- •those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
- •those with intestinal obstruction
- •those with alcoholic hepatitis
- •those with active alcohol or substance abuse
- •those without stable social support
- •those who have a concurrent infection, such as SBP, pneumonia or UTI
- •those with creatinine clearance less than 50% compared to baseline
- •those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
结局指标
主要结局
Portion of participants with normailzation of ICT or Stroop Test during the study
时间窗: 8 weeks
次要结局
- Changes in stool bile acids composition pre and post FMT(8 Weeks)
- Changes in stool short chain fatty acids pre and post FMT(8 weeks)
- Serious Adverse Events(8 weeks)
- Changes in serum ammonia level pre and post FMT(8 weeks)
- Changes in Intestinal Microbiota pre and post FMT(8 weeks)
- Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8(8 weeks)
- Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT(8 weeks)
研究者
Dina Kao
Assistant Professor
University of Alberta
研究点 (1)
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