A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Proportion of participants with Overall Survival at 3 months
研究概览
简要总结
Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences.
Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days.
Monitoring and assessment:
The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.
The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy.
Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 & 180.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe alcoholic hepatitis .
- •Eligible for steroid therapy.
排除标准
- •Upper gastrointestinal bleed within the past one month.
- •Active sepsis
- •Serum creatinine > 1.5 mg/dl (Hepato renal syndrome)
- •Intestinal paralysis
- •Hepatic or extrahepatic malignancy
- •Disseminated intravascular coagulation
- •Discriminant Function (DF) >90
研究组 & 干预措施
Fecal Microbiota Transplantation
干预措施: Fecal Microbiota Transplantation (Other)
Steroid
干预措施: Steroids (Drug)
结局指标
主要结局
Proportion of participants with Overall Survival at 3 months
时间窗: 3 months
次要结局
- Improvement in Child Pugh Turcotte (score) severity in both groups(6 months)
- Improvement in Glasgow Alcoholic Hepatitis (score) in both groups(6 months)
- Improvement in Maddrey's Discriminant Function (score) in both groups(6 months)
- Adverse events in both groups(6 months)
- Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups(6 months)