Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
- Conditions
- Enterocolitis Clostridium Difficile Recurrent
- Interventions
- Biological: RBX2660 (microbiota suspension)Other: Placebo
- Registration Number
- NCT02299570
- Lead Sponsor
- Rebiotix Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- ≥ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group C Placebo 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart Group B Placebo Two enemas of placebo administered 7 days apart Group A RBX2660 (microbiota suspension) Two enemas of RBX2660 (microbiota suspension) administered 7 days apart Group C RBX2660 (microbiota suspension) 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
- Primary Outcome Measures
Name Time Method Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) 8 weeks after last assigned study treatment The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
- Secondary Outcome Measures
Name Time Method Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) 8-weeks Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) 8-weeks Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) 8-weeks Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) 8-week The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) 8-weeks Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) 8-weeks Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Trial Locations
- Locations (21)
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Sanford Health
🇺🇸Fargo, North Dakota, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, 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
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint 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
Regional Infectious Diseases and Infusion Center
🇺🇸Lima, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Louis Stokes Cleveland VA Medical Center
🇺🇸Cleveland, Ohio, United States