NCT03439982已完成1 期
A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Portion of participants with normalization of ICT or Stroop Test during the study
研究概览
简要总结
The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (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 (ICT) and Stroop test as well as fasting 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
- •Abnormal ICT (>5 lures) or abnormal Stroop test (>200 seconds)
- •Baseline Conn score 0 or 1
- •Infectious etiology of HE has been ruled out
排除标准
- •those with tense ascites
- •those who do not provide assent
- •life expectancy <3 months
- •TIPS within the past 3 months
- •neurologic disease such as dementia, Parkinson's, structural brain lesions
- •pregnancy
- •intestinal obstruction
- •alcoholic hepatitis
- •active alcohol or substance abuse
- •those without stable social support
- •concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
- •creatinine clearance less that 50% compared to baseline
- •hospital admission for HE within one month of enrollment
- •active hepatocellular carcinoma
- •active GI bleed
结局指标
主要结局
Portion of participants with normalization of ICT or Stroop Test during the study
时间窗: 8 weeks
次要结局
- Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8(8 weeks)
- Changes in serum ammonia level pre and post FMT(8 weeks)
- Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT(8 weeks)
- Change in Intestinal Microbiota pre-and post FMT(8 weeks)
- Serious Adverse Events(8 weeks)
- Change in stool Bile Acids Composition pre and post FMT(8 Weeks)
- Changes in stool short chain free fatty acids pre and post FMT(8 weeks)
研究者
研究点 (1)
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