Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (PRISM3)
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|ClinicalTrials.gov Identifier: NCT03110133|
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : July 6, 2022
Last Update Posted : October 5, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Recurrence||Drug: Full Spectrum Microbiota Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||February 28, 2020|
|Actual Study Completion Date :||June 18, 2020|
Full Spectrum Microbiota Capsule
Drug: Full Spectrum Microbiota
Orally administered donor derived microbiota
Other Name: CP101, FSM
Placebo Comparator: Placebo
Matching Placebo Capsule
Placebo for CP101
- Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication [ Time Frame: Week 8 ]Defined in the protocol as sustained clinical cure
- Number of Participants With Occurrence of Treatment Emergent Adverse Events [ Time Frame: Week 8 ]Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)
- Time to First Recurrent CDI Episode During the Study [ Time Frame: Week 8 ]The number of days between IP administration and the first C. Difficile recurrence
- Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication [ Time Frame: Week 24 ]Defined in the protocol as sustained clinical cure
- Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype [ Time Frame: Up to Week 8 ]NAP1 is the North American Pulse-field C. difficile subtype.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110133