Research Study

A Prospective Open-Labelled Multi-Centre Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection
Principal Investigator 
Theodore Steiner

Overview

Body Locations and Systems 
Clostridium Difficile Infections
ClinicalTrials.gov# 
NCT02394275
Status 
Recruiting
Study Start/End 
May 8, 2015 to Apr 17, 2017
Locations 
Vancouver General Hospital
Name/Title 
Study Coordinator
Phone 
604-875-4588
Purpose of Study 

The primary goal of this proposal is to study the outcome of patients with recurrent Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the safety of FMT and to determine the clinical response, treatment failure and relapse rate in patients treated with frozen-and-thawed FMT; to assess the functional health and well-being of patients in each arm using the validated tool, and to determine the feasibility of providing standardized FMT in multiple centres across Canada, including community hospitals. 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.