Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT02299570

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Official Title:

A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

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.

Eligibility

Inclusion Criteria:

* ≥ 18 years
* Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
* Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
* A positive stool test for the presence of C. difficile within 60 days prior to enrollment.

Exclusion Criteria:

* A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
* Requires antibiotic therapy for a condition other than recurrent CDI.
* Previous fecal transplant prior to study enrollment.
* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
* History of irritable bowel syndrome (IBS).
* History of chronic diarrhea.
* History of celiac disease.
* Colostomy.
* Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
* Life expectancy of \< 12 months.
* Compromised immune system.

Disease(s) and\or Condition(s)

Enterocolitis Clostridium Difficile Recurrent

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: RBX2660 (microbiota suspension)
    • Description: A suspension of intestinal microbes
    • Arm Group Labels: Group A, Group C
    • Type: OTHER
    • Name: Placebo
    • Description: A suspension of saline and cryoprotectant
    • Arm Group Labels: Group B, Group C
Sponsor
  • Rebiotix Inc.