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

NCT ID: NCT02868164

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-02-28

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.

Conditions

NASH Related Decompensated Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplantation (FMT)

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: DRUG

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

Weight Reduction

Group Type: ACTIVE_COMPARATOR

Standard Treatment

Intervention Type: DRUG

Standard Treatment

Weight Reduction

Intervention Type: OTHER

routine exercise for weight reduction

Interventions

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.

Intervention Type: DRUG

Standard Treatment

Standard Treatment

Intervention Type: DRUG

Weight Reduction

routine exercise for weight reduction

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Kapil Dev Jamwal, DM

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-Cirrhosis-05

Identifier Type: -

Identifier Source: org_study_id