Last updated on October 2016

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Clostridium Difficile Infection
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    ≥ 18 years old.
    Medical record documentation of recurrent CDI including a positive C. difficile test
    within 60 days prior to enrollment and 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
    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

You may not be eligible for this study if the following are true:

  • A known history of continued CDI diarrhea despite being on a course of antibiotics
    prescribed for CDI treatment.
    Requires continuous antibiotic therapy for a condition other than CDI.
    Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI <
    6 months prior to study enrollment.
    Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
    Previous treatment with RBX2660.
    Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's
    disease, or microscopic colitis.
    Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
    History of chronic diarrhea.
    History of celiac disease.
    Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
    Planned surgery requiring perioperative antibiotics within 3 months of study
    Life expectancy of < 12 months.
    Compromised immune system

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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