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

NCT02868164 | Withdrawn

• 1 other identifier: ILBS-Cirrhosis-05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

  1 year

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

  1 year

Study Arms (2)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

Drug: Fecal Microbiota Transplantation

Weight Reduction

ACTIVE COMPARATOR

Drug: Standard Treatment; Other: Weight Reduction

Interventions

Fecal Microbiota Transplantation DRUG

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

Fecal Microbiota Transplantation (FMT)

Standard Treatment DRUG

Standard Treatment

Weight Reduction

Weight Reduction OTHER

routine exercise for weight reduction

Weight Reduction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Dr Kapil Dev Jamwal, DM

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 16, 2016
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2018-02

Locations

IN (1)