Non Alcoholic Steatohepatitis
Conditions
Brief summary
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.
Interventions
BIOLOGICALFecal Microbiota Transplant
OTHERStandard Medical Treatment
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline. | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR) | 1 year | HOMA IR \<2.5 |
| Improvement in liver function test as compared to baseline. | 1 year | Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits |
| development of new onset of ascites in both groups. | 1 year | — |
| Incidence of new onset upper gastrointestinal bleed 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 | — |
| Improvement in Liver Stiffness Measurement as compared to baseline. | 1 year | LSM \< 10 Kpa |
Countries
India
Contacts
Primary ContactDr Abhinav Verma, MD
Outcome results
None listed