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

Primary Purpose

NASH Related Decompensated Cirrhosis

Status

Withdrawn

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Fecal Microbiota Transplantation

Standard Treatment

Weight Reduction

About this trial

This is an interventional treatment trial for NASH Related Decompensated Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age more than 18 years.
All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
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).
No history of recent spontaneous bacterial peritonitis.(1 month)
Child Pugh Score of 6 - 10

Exclusion Criteria:

Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
Ongoing bacterial infection requiring antibiotic treatment.
Current or history of significant alcohol consumption for a period of more than 3
consecutive months within 1 year prior to screening
Treatment with antibiotics or probiotics in the preceding 3 months.
Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
Pregnant patients

Sites / Locations

Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fecal Microbiota Transplantation (FMT)

Weight Reduction

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month

Improvement in liver function test as compared to baseline in both groups.

Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.

Improvement duodenal biopsy as compared to baseline in both groups.

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.

Improvement in insulin resistance in both groups.

Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR

Reduction in hepatic and systemic inflammatory markers in both groups

Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.

Full Information

NCT ID

NCT02868164

First Posted

August 4, 2016

Last Updated

October 30, 2019

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02868164

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Why Stopped

lack of funds

Study Start Date

February 2018 (Anticipated)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NASH Related Decompensated Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fecal Microbiota Transplantation (FMT)

Arm Type

Experimental

Arm Title

Weight Reduction

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Fecal Microbiota Transplantation

Intervention Description

The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.

Intervention Type

Drug

Intervention Name(s)

Standard Treatment

Intervention Description

Standard Treatment

Intervention Type

Other

Intervention Name(s)

Weight Reduction

Intervention Description

routine exercise for weight reduction

Primary Outcome Measure Information:

Title

Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups

Description

Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month

Time Frame

1 year

Title

Improvement in liver function test as compared to baseline in both groups.

Time Frame

1 year

Title

Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.

Time Frame

1 year

Title

Improvement duodenal biopsy as compared to baseline in both groups.

Description

Improvement is defined as improvement in microbiome pre and post treatment.

Time Frame

1 year

Title

Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.

Time Frame

1 year

Title

Improvement in insulin resistance in both groups.

Description

Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR

Time Frame

1 year

Title

Reduction in hepatic and systemic inflammatory markers in both groups

Description

Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age more than 18 years. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis. 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). No history of recent spontaneous bacterial peritonitis.(1 month) Child Pugh Score of 6 - 10 Exclusion Criteria: Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis Ongoing bacterial infection requiring antibiotic treatment. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening Treatment with antibiotics or probiotics in the preceding 3 months. Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy Pregnant patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Kapil Dev Jamwal, DM

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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