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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: NASH Related Decompensated Cirrhosis

Treatments: Other: Weight Reduction; Drug: Fecal Microbiota Transplantation; Drug: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02868164

ILBS-Cirrhosis-05

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Fecal Microbiota Transplantation (FMT)

Experimental group

Treatment:

Drug: Fecal Microbiota Transplantation

Weight Reduction

Active Comparator group

Treatment:

Drug: Standard Treatment

Other: Weight Reduction