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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

NCT02589847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-03-26

Study results available
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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

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

RBX2660

suspension of intestinal microbes

DRUG

Standard of Care Antibiotics

Standard of Care Antibiotics

Sponsors & Collaborators

  • Rebiotix Inc.

    lead INDUSTRY

Principal Investigators

  • Arnab Ray, MD · Ochsner Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-06-30
Completion
2019-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT02589847 on ClinicalTrials.gov