Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round 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. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

Inclusion criteria

• ≥ 18 years old.
• Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
• Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]

Exclusion criteria

• Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
• Requires systemic antibiotic therapy for a condition other than CDI.
• Fecal microbiota transplant (FMT) within the past 6 months.
• FMT with an associated serious adverse event related to the FMT product or procedure.
• Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
• CD4 count <200/mm^3 during Screening.
• An absolute neutrophil count of <1000 cells/µL during Screening.
• Pregnant, breastfeeding, or intends to become pregnant during study participation.