Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Status:
Completed
Trial end date:
2020-06-18
Target enrollment:
Participant gender:
Summary
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules
one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose
of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence
of C. difficile.
Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study
drug (CP101 or placebo) may be eligible to enroll in the open-label extension study
(CP101-CDI-E02) and will receive CP101.