Clinical trialNCT02299570CompletedPhase 2Interventional

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

SponsorRebiotix Inc.Enrollment150Enterocolitis Clostridium Difficile Recurrent

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Teena Chopra, MD MPH
Wayne State University
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of British Columbia
Vancouver, British Columbia, Canada
St. Joseph'S Hospital
Hamilton, Ontario, Canada

United States

Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Grand Teton Research Group
Idaho Falls, Idaho, United States
Loyola University Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Infectious Diseases of Indiana
Indianapolis, Indiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Hospital Queens
Flushing, New York, United States
New York-Presbyterian Hospital/weill Cornell Medical College
New York, New York, United States
Gastroenterology Group of Rochester
Rochester, New York, United States
Sanford Health
Fargo, North Dakota, United States
Louis Stokes Cleveland Va Medical Center
Cleveland, Ohio, United States
Regional Infectious Diseases and Infusion Center
Lima, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

RBX2660

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2014
Primary completion: 31 Jan 2016
Completion: 31 Jan 2018
Last update posted: 15 Jan 2021
Registered enrollment: 150
Registry id: NCT02299570

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.