Title
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
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
Phase
Phase 2Lead Sponsor
Crestovo LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Clostridium Difficile Infection RecurrenceIntervention/Treatment
microbiota ...Study Participants
206Subjects 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.
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).
Orally administered donor derived microbiota
Placebo for CP101
Inclusion Criteria: Ability to provide written informed consent Men or women 18 years of age or older Current diagnosis of a recurrence of non-severe, non-complicated CDI Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode Exclusion Criteria: Pregnant, breast-feeding, or considering becoming pregnant during the study Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) Any prior diagnosis of diarrhea-predominant irritable bowel syndrome Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study Major intra-abdominal surgery within the past 60 days prior to Screening History of total colectomy/ileostomy or bariatric surgery Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry Planned hospitalization or invasive surgery during the study Severe acute illness unrelated to CDI
| Event Type | Organ System | Event Term | CP101 | Placebo |
|---|
Defined in the protocol as sustained clinical cure
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)
The number of days between IP administration and the first C. Difficile recurrence
Defined in the protocol as sustained clinical cure
NAP1 is the North American Pulse-field C. difficile subtype.
