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NCT02299570 · ClinicalTrials.gov registry record · Phase 2
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
A Phase 2 study of Enterocolitis Clostridium Difficile Recurrent, sponsored by Rebiotix.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT02299570: Completed Phase 2 study of Enterocolitis Clostridium Difficile Recurrent, sponsored by Rebiotix.
NCT02299570 is a Phase 2 study of Enterocolitis Clostridium Difficile Recurrent that has completed, run by Rebiotix. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299570, a Phase 2 study of Enterocolitis Clostridium Difficile Recurrent, has completed, sponsored by Rebiotix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL RBX2660 (microbiota suspension)
Study Locations (20)
New York
- New York Hospital Queens - Flushing
- New York-Presbyterian Hospital/Weill Cornell Medical College - New York
- Gastroenterology Group of Rochester - Rochester
Illinois
- Loyola University Chicago - Chicago
- University of Chicago - Chicago
Minnesota
- Mayo Clinic Minnesota - Rochester
- Regions Hospital - Saint Paul
Ohio
- Louis Stokes Cleveland VA Medical Center - Cleveland
- Regional Infectious Diseases and Infusion Center - Lima
Arizona
- Mayo Clinic Arizona - Phoenix
Colorado
- University of Colorado - Aurora
Florida
- Borland-Groover Clinic - Jacksonville
Idaho
- Grand Teton Research Group - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT02299570 record still lists
NCT02299570 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Enterocolitis Clostridium Difficile Recurrent appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02299570 names 20 study sites across 15 states, led by New York, Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02299570 about?
NCT02299570 is a clinical study titled "Microbiota Restoration Therapy for 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 stand...
What is the current status of trial NCT02299570?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2014-12. Estimated completion is 2018-01.
What conditions does trial NCT02299570 study?
This clinical trial studies the following conditions: Enterocolitis Clostridium Difficile Recurrent.
What interventions are being tested in trial NCT02299570?
The interventions under investigation include: Placebo (OTHER), RBX2660 (microbiota suspension) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02299570?
This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02299570 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02299570's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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