Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection



Status:Completed
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/7/2018
Start Date:December 2014
End Date:January 2018

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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

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.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a
microbiota suspension derived from intestinal microbes. The primary assessments for this
study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via
assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with
additional follow-up at 3, 6 12 and 24 months post treatment. 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.

Inclusion Criteria:

- ≥ 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.

Exclusion Criteria:

- 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.
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Flushing, New York 11355
Phone: 718-670-1633
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-1665
University of Chicago One of the world's premier academic and research institutions, the University of...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Phone: 904-680-0871
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 215-349-8527
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Aurora, Colorado 80045
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Chevy Chase, Maryland 20815
Phone: 301-652-5520
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1200 West Loyola Avenue
Chicago, Illinois 60626
Phone: 708-216-6638
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Cleveland, Ohio 44106
Phone: 972-207-6044
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Detroit, Michigan 48202
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Fargo, North Dakota 58122
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Indianapolis, Indiana 46260
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Lima, Ohio 45801
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New York, New York 10065
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Phoenix, Arizona 85054
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Rochester, Minnesota 55905
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Rochester, New York 14618
Phone: 585-271-2800
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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640 Jackson Street
Saint Paul, Minnesota 55101
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Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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Vancouver, British Columbia V6T 1W5
Phone: (604) 875-4111
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