Research Study

A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Principal Investigator 
Theodore Steiner

Overview

Body Locations and Systems 
Clostridium Difficile Infections
ClinicalTrials.gov# 
NCT02299570
Status 
Closed to Recruitment
Study Start/End 
Apr 1, 2015 to Jan 1, 2018
Locations 
Diamond Health Care Centre
Name/Title 
Kessie Xu, Research Coordinator
Phone 
604-875-4111 ext.69487
Email Address 
kessie.xu@vch.ca
Purpose of Study 

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) 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 may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.


 

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.