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Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

NCT01925417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-11-13

Study results available
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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

  • Recurrent Clostridium Difficile Infection

Interventions

BIOLOGICAL

RBX2660 (microbiota suspension)

Sponsors & Collaborators

  • Rebiotix Inc.

    lead INDUSTRY

Principal Investigators

  • Dimitri Drekonja, MD · Veteran Administration Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-03-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925417 on ClinicalTrials.gov