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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month. |
|
| Standard Treatment Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant | Biological |
| ||
| Standard Medical Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline. | 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Abhinav Verma, MD | Contact | 011-46300000 | abhinav.3183@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Abhinav Verma, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40568349 | Derived | Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Other |
|
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 |