NCT02689245已完成不适用
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Transplant free survival.
研究概览
简要总结
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.
Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).
Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
- •18-75 yr both male and female
- •Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
- •Healthy adult family member of the patient will be taken as a control.
排除标准
- •Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
- •Active gastrointestinal bleeding
- •Intracranial bleeding
- •Multi-organ failure (>2) on mechanical ventilation
- •SOFA score >2
- •On high inotropic support
- •Paralytic ileus
- •Pregnancy
- •Hepatocellular Carcinoma
- •Antibiotic,probiotic within last 3 months
研究组 & 干预措施
Tenofovir + Fecal Microbiota Transplantation (FMT)
Experimental
干预措施: Tenofovir (Drug)
Tenofovir + Fecal Microbiota Transplantation (FMT)
Experimental
干预措施: Fecal Microbiota Transplantation (FMT) (Drug)
Tenofovir
Active Comparator
干预措施: Tenofovir (Drug)
结局指标
主要结局
Transplant free survival.
时间窗: 3 months
次要结局
- Reduction in Hepatitis B Virus DNA level ≥ 2 log.(2 weeks)
- Improvement in MELD (Model for End Stage Liver Disease) score.(2 weeks)
- Improvement in CTP (Child Pugh Turcotte) score.(2 weeks)
- Mortality(3 Months)
- Improvement in hepatic Encephalopathy.(7 days)
- Improvement in International Normalized ratio.(7 days)
- Improvement in Total bilirubin.(7 days)
- Development of infectious complications during follow up in both groups(7,15,30 and 90 days)
- Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups(7,15,30 and 90 days)
- Improvement in SOFA (Sequential organ failure assessment) score in both groups.(7,15,30 and 90 days)
- Change in gut microbiome in both the groups(0,7,15,30 and 90 days)
- Assessment of organ failures in both groups(7,15,30 and 90 days)
研究者
研究点 (1)
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