To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Survival in both groups
研究概览
简要总结
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.
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
- Double (Participant, Investigator)
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
- •Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option
排除标准
- •Culture Positive Sepsis
- •History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate
- •Receiving psychoactive drugs, promotility and hypomotility drugs
- •Pregnant females
研究组 & 干预措施
Standard Medical Treatment+Fecal Microbiota Transplant
干预措施: Standard Medical Treatment (Drug)
Standard Medical Treatment+Fecal Microbiota Transplant
干预措施: Fecal Microbiota Transplant (Other)
Standard Medical Treatment+Placebo
干预措施: Standard Medical Treatment (Drug)
Standard Medical Treatment+Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Survival in both groups
时间窗: Day 21
次要结局
- Reduction of ammonia in both groups(Day 1,2,5,7,14,21)
- Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups(Day 1,2,5,7,14,21)
- Improvement of Cerebral edema in both groups(Day 1,2,5,7,14,21)
- Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups(Day 21)