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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental |
| |
| Weight Reduction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Drug | The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups | Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month | 1 year | |
| Improvement in liver function test as compared to baseline in both groups. | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Kapil Dev Jamwal, DM | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Standard Treatment | Drug | Standard Treatment |
|
| Weight Reduction | Other | routine exercise for weight reduction |
|
| 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. | Improvement is defined as improvement in microbiome pre and post treatment. | 1 year |
| Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups. | 1 year |
| Improvement in insulin resistance in both groups. | Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR | 1 year |
| Reduction in hepatic and systemic inflammatory markers in both groups | Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins. | 1 year |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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