Last updated on October 2016

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection


Brief description of study

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

Detailed Study Description

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. The primary assessments for this study are (i) to assess efficacy as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660 and (ii) safety via assessment of adverse events. Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

Clinical Study Identifier: NCT02589847

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