Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Alcoholic Steatohepatitis

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 HIV Pregnant women Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation (FMT)<br>The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month. | Biological: Fecal Microbiota Transplant<br> <br> |
| Active Comparator: Standard Treatment Care<br> | Other: Standard Medical Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in liver function test as compared to baseline. | Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits | 1 year | 
| Improvement in Liver Stiffness Measurement as compared to baseline. | LSM < 10 Kpa | 1 year | 
| Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR) | HOMA IR <2.5 | 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 | 
| Number of Spontaneous Bacterial peritonitis cases 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 TNF-α in both groups |  | 1 year | 
| Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups |  | 1 year | 
| Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups. |  | 1 year | 
| Histological and permeability changes in the duodenal biopsy in both groups. |  | 1 year |