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NCT02589847 · ClinicalTrials.gov registry record · Phase 2

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

A Phase 2 study of Clostridium Difficile Infection, sponsored by Rebiotix.

Completed
Registry status
Phase 2
Development phase
272
Enrollment target
20
Study locations

NCT02589847 is a Phase 2 study of Clostridium Difficile Infection that has completed, run by Rebiotix. The registered enrollment target is 272 participants, below the 12,045-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT02589847, a Phase 2 study of Clostridium Difficile Infection, has completed, sponsored by Rebiotix.

COMPLETED
Registry status
Phase 2
Development phase
272 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Conditions Studied

Clostridium Difficile Infection

Interventions

  • BIOLOGICAL RBX2660
  • DRUG Standard of Care Antibiotics

Study Locations (20)

Florida

  • - Bay Pines
  • - Coral Springs
  • - Gainesville
  • - Miami

Illinois

  • - Chicago
  • - Maywood

Indiana

  • - Indianapolis
  • - Lafayette

Minnesota

  • - Rochester
  • - Saint Paul

New York

  • - Flushing
  • - Rochester

Arizona

  • - Phoenix

Arkansas

  • - North Little Rock

California

  • - Sacramento

Trial Details

FieldValue
Enrollment Target 272 participants
Start Date 2015-10
Est. Completion 2019-03
Phase Phase 2

Sponsor

Rebiotix

5 total trials

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What the Registry Record Tells You About NCT02589847

The ClinicalTrials.gov registry entry for NCT02589847 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,045-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower). The listed sponsor is Rebiotix, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 2 interventions - of which RBX2660 is the first listed.

NCT02589847 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT02589847 about?

NCT02589847 is a clinical study titled "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection". This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consist...

What is the current status of trial NCT02589847?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2015-10. Estimated completion is 2019-03.

What conditions does trial NCT02589847 study?

This clinical trial studies the following conditions: Clostridium Difficile Infection.

What interventions are being tested in trial NCT02589847?

The interventions under investigation include: RBX2660 (BIOLOGICAL), Standard of Care Antibiotics (DRUG).

Who is sponsoring clinical trial NCT02589847?

This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02589847 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.