Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of
intestinal microbes. 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.