Research Study

A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed Human Biotherapy (Fecal Transplant) for Recurrent Clostridium Difficile Infection
Principal Investigator 
Theodore Steiner

Overview

Body Locations and Systems 
Clostridium Difficile Infections
ClinicalTrials.gov# 
NCT01398969
Status 
Closed to Recruitment
Study Start/End 
Dec 31, 2013 to Apr 1, 2017
Locations 
Diamond Health Care Centre, Vancouver General Hospital
Name/Title 
Rory-Lynn Cunada, Research Nurse
Phone 
604-875-5077
Purpose of Study 

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh HBT versus frozen-and-thawed HBT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of HBT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh HBT compared to those treated with frozen-and-thawed HBT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.

Eligibility 

Visit ClinicalTrials.gov for more information. 

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.