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Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Primary Purpose

Non Alcoholic Steatohepatitis

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Fecal Microbiota Transplant

Standard Medical Treatment

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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 or perform an upper GI endoscopy
Psychiatric disorder
HIV
Pregnant women
Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

Sites / Locations

Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fecal Microbiota Transplantation (FMT)

Standard Treatment Care

Arm Description

The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month.

Outcomes

Primary Outcome Measures

Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.

Secondary Outcome Measures

Improvement in liver function test as compared to baseline.

Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits

Improvement in Liver Stiffness Measurement as compared to baseline.

LSM < 10 Kpa

Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)

HOMA IR <2.5

Incidence of new onset upper gastrointestinal bleed in both groups

development of new onset of ascites in both groups.

Number of Spontaneous Bacterial peritonitis cases in both groups.

ACLF (Acute on Chronic Liver failure) cases in both groups.

Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups

Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups

Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.

Histological and permeability changes in the duodenal biopsy in both groups.

Full Information

NCT ID

NCT02721264

First Posted

March 1, 2016

Last Updated

February 13, 2018

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02721264

Brief Title

Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2016 (Actual)

Primary Completion Date

June 30, 2018 (Anticipated)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

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

Non Alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fecal Microbiota Transplantation (FMT)

Arm Type

Experimental

Arm Description

The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month.

Arm Title

Standard Treatment Care

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Fecal Microbiota Transplant

Intervention Type

Other

Intervention Name(s)

Standard Medical Treatment

Primary Outcome Measure Information:

Title

Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Improvement in liver function test as compared to baseline.

Description

Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits

Time Frame

1 year

Title

Improvement in Liver Stiffness Measurement as compared to baseline.

Description

LSM < 10 Kpa

Time Frame

1 year

Title

Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)

Description

HOMA IR <2.5

Time Frame

1 year

Title

Incidence of new onset upper gastrointestinal bleed in both groups

Time Frame

1 year

Title

development of new onset of ascites in both groups.

Time Frame

1 year

Title

Number of Spontaneous Bacterial peritonitis cases in both groups.

Time Frame

1 year

Title

ACLF (Acute on Chronic Liver failure) cases in both groups.

Time Frame

1 year

Title

Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups

Time Frame

1 year

Title

Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups

Time Frame

1 year

Title

Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.

Time Frame

1 year

Title

Histological and permeability changes in the duodenal biopsy in both groups.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 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 or perform an upper GI endoscopy Psychiatric disorder HIV Pregnant women Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Abhinav Verma, MD

Phone

011-46300000

abhinav.3183@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Abhinav Verma, MD

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Liver & Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

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