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

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.

Study Overview

• Status: Withdrawn
• Conditions: NASH Related Decompensated Cirrhosis
• Intervention / Treatment: Drug: Fecal Microbiota Transplantation; Drug: Standard Treatment; Other: Weight Reduction

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation (FMT)	Drug: Fecal Microbiota Transplantation; The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
Active Comparator: Weight Reduction	Drug: Standard Treatment; Standard Treatment; Other: Weight Reduction; routine exercise for weight reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Kapil Dev Jamwal, DM, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 13, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No