Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.

Not Applicable

Withdrawn

• Conditions: NASH Related Decompensated Cirrhosis
• Interventions: Drug: Fecal Microbiota Transplantation; Drug: Standard Treatment; Other: Weight Reduction

• Registration Number: NCT02868164
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-13
• Study First Posted: 2016-08-16
• Status Verified: 2018-02
• Study Start: 2018-02
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation (FMT)	Fecal Microbiota Transplantation	-
Weight Reduction	Standard Treatment	-
Weight Reduction	Weight Reduction	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.	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.
Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month	1 year

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India