Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
Status:
Withdrawn
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
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.