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Fecal Microbiota Transplantation for Decompensated Cirrhosis — FMTDC  

Fecal Microbiota Transplantation Clinical Trial

Official title:
Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial

Clinical Trial Summary

Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.

Clinical Trial Description

Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03014505
Study type Interventional
Source First Affiliated Hospital of Chengdu Medical College
Contact Yan Zhou, Ph.D
Phone +86-18981941992
Email zqlvzy319@163.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 2016
Completion date July 2018
View Details
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