Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Status:
Completed
Trial end date:
2020-08-03
Target enrollment:
Participant gender:
Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3
study of a microbiota suspension of intestinal microbes. Patients who have had at least one
recurrence 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 within the last year may be eligible for the study. Subjects who are deemed
failures following the blinded treatment per the pre-specified treatment failure definition
may elect to receive an unblinded RBX2660 enema.