NCT02868164

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Standard Treatment	Standard Treatment
OTHER	Weight Reduction	routine exercise for weight reduction

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2016-08-16
• Last updated: 2019-11-01

Locations

1 site across 1 country: India