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
Last Update Posted : January 11, 2021
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Sponsor:
Finch Research and Development LLC.
Information provided by (Responsible Party):
Finch Research and Development LLC.
Tracking Information | |||||
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First Submitted Date ICMJE | April 3, 2017 | ||||
First Posted Date ICMJE | April 12, 2017 | ||||
Last Update Posted Date | January 11, 2021 | ||||
Actual Study Start Date ICMJE | May 8, 2017 | ||||
Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Detailed Description | This is 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 (CDI). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Clostridium Difficile Infection Recurrence | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
206 | ||||
Original Estimated Enrollment ICMJE |
240 | ||||
Actual Study Completion Date ICMJE | June 18, 2020 | ||||
Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03110133 | ||||
Other Study ID Numbers ICMJE | CDI-001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Finch Research and Development LLC. | ||||
Study Sponsor ICMJE | Finch Research and Development LLC. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Finch Research and Development LLC. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |