Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01925417 · ClinicalTrials.gov registry record · Phase 2
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
A Phase 2 study of Recurrent Clostridium Difficile Infection, sponsored by Rebiotix.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 13
- Study locations
NCT01925417: Completed Phase 2 study of Recurrent Clostridium Difficile Infection, sponsored by Rebiotix.
NCT01925417 is a Phase 2 study of Recurrent Clostridium Difficile Infection that has completed, run by Rebiotix. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925417, a Phase 2 study of Recurrent Clostridium Difficile Infection, has completed, sponsored by Rebiotix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.
Primary Outcome
Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
Conditions Studied
Interventions
- BIOLOGICAL RBX2660 (microbiota suspension)
Study Locations (13)
Illinois
- Edward Hines Jr VA Hospital (veterans only) - Chicago
- University of Chicago - Chicago
Michigan
- Detroit Medical Center - Detroit
- Henry Ford Health System - Detroit
Arizona
- Mayo Clinic Arizona - Phoenix
Colorado
- Denver Health and University of Colorado - Denver
Florida
- Borland-Groover Clinic - Jacksonville
Louisiana
- Ochsner Clinic - New Orleans
Maryland
- Chevy Chase Clinical Research - Chevy Chase
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01925417 record still lists
NCT01925417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Recurrent Clostridium Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which RBX2660 (microbiota suspension) is the first listed.
NCT01925417 lists 13 locations in 11 states (Illinois, Michigan, Arizona).
Frequently Asked Questions
What is clinical trial NCT01925417 about?
NCT01925417 is a clinical study titled "Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea". This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.
What is the current status of trial NCT01925417?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2013-08. Estimated completion is 2014-07.
What conditions does trial NCT01925417 study?
This clinical trial studies the following conditions: Recurrent Clostridium Difficile Infection.
What interventions are being tested in trial NCT01925417?
The interventions under investigation include: RBX2660 (microbiota suspension) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01925417?
This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01925417 being conducted?
This trial has 13 study locations across Arizona, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Clostridium Difficile Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01925417's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia