MedTrace Logo

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

NCT02299570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-01-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Enterocolitis Clostridium Difficile Recurrent

Interventions

BIOLOGICAL

RBX2660 (microbiota suspension)

A suspension of intestinal microbes

OTHER

Placebo

A suspension of saline and cryoprotectant

Sponsors & Collaborators

  • Rebiotix Inc.

    lead INDUSTRY

Principal Investigators

  • Teena Chopra, MD MPH · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-01-31
Completion
2018-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT02299570 on ClinicalTrials.gov