Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Enterocolitis Clostridium Difficile Recurrent

In brief

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.

Key facts

Study ID

NCT02299570

Run by

Rebiotix Inc.

People needed

150

Starts

2014-12-01

Expected to finish

2018-01-01

Last updated by the study team

2021-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years
• Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
• Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
• A positive stool test for the presence of C. difficile within 60 days prior to enrollment.

You may not qualify if…

• A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
• Requires antibiotic therapy for a condition other than recurrent CDI.
• Previous fecal transplant prior to study enrollment.
• History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
• History of irritable bowel syndrome (IBS).
• History of chronic diarrhea.
• History of celiac disease.
• Colostomy.
• Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
• Life expectancy of < 12 months.
• Compromised immune system.

Where it is running

• 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
• University of British Columbia — Vancouver, British Columbia, Canada
• St. Joseph's Hospital — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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