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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
Standard Treatment
routine exercise for weight reduction
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
Time frame: 1 year
Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month
Time frame: 1 year
Improvement in liver function test as compared to baseline in both groups.
Time frame: 1 year
Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.
Time frame: 1 year
Improvement duodenal biopsy as compared to baseline in both groups.
Improvement is defined as improvement in microbiome pre and post treatment.
Time frame: 1 year
Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.
Time frame: 1 year
Improvement in insulin resistance in both groups.
Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers in both groups
Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.
Time frame: 1 year
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