NASH Related Decompensated Cirrhosis
Conditions
Brief summary
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.
Interventions
DRUGFecal Microbiota Transplantation
The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
DRUGStandard Treatment
Standard Treatment
OTHERWeight Reduction
routine exercise for weight reduction
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 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age more than 18 years. 2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis. 3. 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). 4. No history of recent spontaneous bacterial peritonitis.(1 month) 5. Child Pugh Score of 6 - 10
Exclusion criteria
1. Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis 2. Ongoing bacterial infection requiring antibiotic treatment. 3. Current or history of significant alcohol consumption for a period of more than 3 4. 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 in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy 7. Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups | 1 year | Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 is defined as improvement in microbiome pre and post treatment. |
| Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month | 1 year | — |
| Improvement in insulin resistance in both groups. | 1 year | Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR |
| Reduction in hepatic and systemic inflammatory markers in both groups | 1 year | Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins. |
| Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups. | 1 year | — |
Countries
India
Outcome results
None listed