Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fecal Microbiota Transplantation (FMT) 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
|
| Active Comparator: Standard Treatment Care
|
Other: Standard Medical Treatment
|
Outcome Measures
Primary Outcome Measures
- Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline. [1 year]
Secondary Outcome Measures
- Improvement in liver function test as compared to baseline. [1 year]
Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits
- Improvement in Liver Stiffness Measurement as compared to baseline. [1 year]
LSM < 10 Kpa
- Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR) [1 year]
HOMA IR <2.5
- 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]
Eligibility Criteria
Criteria
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
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Ongoing bacterial infection requiring antibiotic treatment.
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Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
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Treatment with antibiotics or probiotics in the preceding 3 months.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Liver & Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
- Principal Investigator: Dr Abhinav Verma, MD, Institute of Liver and Biliary Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILBS-NASH-03