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Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
NCT01925417 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01925417
The ClinicalTrials.gov registry entry for NCT01925417 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rebiotix, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01925417 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Illinois, Michigan, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01925417?
The interventions under investigation include: RBX2660 (microbiota suspension) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01925417?
This trial is sponsored by Rebiotix, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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