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COMPLETED Phase 2

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

NCT02299570 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2014-12
Est. Completion 2018-01
Phase Phase 2

Sponsor

Rebiotix

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02299570

The ClinicalTrials.gov registry entry for NCT02299570 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 150 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 Enterocolitis Clostridium Difficile Recurrent appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02299570 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Illinois, Minnesota. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02299570?

The interventions under investigation include: Placebo (OTHER), RBX2660 (microbiota suspension) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02299570?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial