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
Brief Description Of Study
Rebiotix Incs RBX2660 (microbiota suspension) is an intestinal microbial suspension intended to treat recurrent Clostridium difficile infection (CDI). RBX2660 is administered via enema and is for rectal use only. Administration of similar products, commonly known as fecal transplants (FT), have documented significant clinical evidence of safe and effective use for over 50 years in over 500 patients. The literature shows significant efficacy (greater than, or equal to, 89%; Bakken, 2009; Brandt and Reddy, 2011; Gough, et al., 2011; van Nood et al., 2009) with very few reported adverse events, none of which have an established causal relationship to the FT product. Rebiotix is conducting a Phase 2B prospective, multicenter, randomized, double-blinded, placebo-controlled, 3-arm study designed to demonstrate the efficacy and safety of RBX2660 for the treatment of recurrent CDI in adults who have had either a) at least two recurrences after a primary episode and have completed at least two rounds of standard of- care oral antibiotic therapy (i.e., at least three episodes) or b) have had at least two episodes of severe CDAD resulting in hospitalization.