NCT02721264Unknown不适用
Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
研究概览
简要总结
Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more then 18 years.
- •All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- •Histologic evidence of definite or probable NASH based upon a liver biopsy prior to enrollment and a NAFLD activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
- •No past history of upper GI bleeding, ascites, hepatic encephalopathy
排除标准
- •Diagnosis of liver disease other than NASH cirrhosis
- •History of gastrointestinal bleeding, ascites, hepatic encephalopathy
- •Ongoing bacterial infection requiring antibiotic treatment.
- •Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
- •Treatment with antibiotics or probiotics in the preceding 3 months.
- •Inability to safely obtain a liver biopsy or perform an upper GI endoscopy
- •Psychiatric disorder
- •Pregnant women
- •Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis
结局指标
主要结局
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
时间窗: 1 year
次要结局
- Histological and permeability changes in the duodenal biopsy in both groups.(1 year)
- Incidence of new onset upper gastrointestinal bleed in both groups(1 year)
- development of new onset of ascites in both groups.(1 year)
- Improvement in Liver Stiffness Measurement as compared to baseline.(1 year)
- Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)(1 year)
- Improvement in liver function test as compared to baseline.(1 year)
- Number of Spontaneous Bacterial peritonitis cases in both groups.(1 year)
- Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups(1 year)
- Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups(1 year)
- ACLF (Acute on Chronic Liver failure) cases in both groups.(1 year)
- Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.(1 year)
研究者
研究点 (2)
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