Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Non Alcoholic Steatohepatitis
• Intervention / Treatment: Biological: Fecal Microbiota Transplant; Other: Standard Medical Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age more then 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. 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).
4. No past history of upper GI bleeding, ascites, hepatic encephalopathy

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH cirrhosis
2. History of gastrointestinal bleeding, ascites, hepatic encephalopathy
3. Ongoing bacterial infection requiring antibiotic treatment.
4. Current or history of significant alcohol consumption for a period of more than 3 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 or perform an upper GI endoscopy
7. Psychiatric disorder
8. HIV
9. Pregnant women
10. Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.	1 year

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Abhinav Verma, MD, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ILBS-NASH-03

Plan for Individual participant data (IPD)

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