Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial

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.

Inclusion Criteria:

1. Age more then 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. 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).
4. No past history of upper GI bleeding, ascites, hepatic encephalopathy

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH cirrhosis
2. History of gastrointestinal bleeding, ascites, hepatic encephalopathy
3. Ongoing bacterial infection requiring antibiotic treatment.
4. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
5. Treatment with antibiotics or probiotics in the preceding 3 months.
6. Inability to safely obtain a liver biopsy or perform an upper GI endoscopy
7. Psychiatric disorder
8. HIV
9. Pregnant women
10. Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis