Research Study

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection
Principal Investigator 
Theodore Steiner

Overview

Body Locations and Systems 
Clostridium Difficile Infections
ClinicalTrials.gov# 
NCT03244644
Status 
Recruiting
Study Start/End 
Oct 13, 2017 to Oct 31, 2018
Locations 
Diamond Health Care Centre
Name/Title 
Neila Tong, Clinical Research Coordinator
Phone 
604-875-4111 ext.62178
Email Address 
neila.tong@vch.ca
Purpose of Study 

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

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 research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.