Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
研究概览
简要总结
The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.
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
- •Age more than 18 years.
- •All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- •Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) 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 history of recent spontaneous bacterial peritonitis.(1 month)
- •Child Pugh Score of 6 - 10
排除标准
- •Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
- •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 in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
- •Pregnant patients
研究组 & 干预措施
Fecal Microbiota Transplantation (FMT)
干预措施: Fecal Microbiota Transplantation (Drug)
Weight Reduction
干预措施: Standard Treatment (Drug)
Weight Reduction
干预措施: Weight Reduction (Other)
结局指标
主要结局
Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
时间窗: 1 year
Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
次要结局
- Improvement in liver function test as compared to baseline in both groups.(1 year)
- Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.(1 year)
- Improvement duodenal biopsy as compared to baseline in both groups.(1 year)
- Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.(1 year)
- Improvement in insulin resistance in both groups.(1 year)
- Reduction in hepatic and systemic inflammatory markers in both groups(1 year)
- Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month(1 year)