Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Clostridium Difficile Infection Recurrence

Intervention / Treatment
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* Drug: Full Spectrum Microbiota
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP101<br>Full Spectrum Microbiota Capsule | Drug: Full Spectrum Microbiota<br>* Orally administered donor derived microbiota<br>* Other names: CP101, FSM;|
| Placebo Comparator: Placebo<br>Matching Placebo Capsule | Drug: Placebo<br>* Placebo for CP101<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | Defined in the protocol as sustained clinical cure | Week 8 | 
| Number of Participants With Occurrence of Treatment Emergent Adverse Events | 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) | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Recurrent CDI Episode During the Study | The number of days between IP administration and the first C. Difficile recurrence | Week 8 | 
| Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | Defined in the protocol as sustained clinical cure | Week 24 | 
| Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype | NAP1 is the North American Pulse-field C. difficile subtype. | Up to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rCDI, C. diff, Recurrent CDI, Clostridium Difficile Infection, CP101, Crestovo, FMT, CDI, C. difficile, Recurrent Clostridium Difficile Infection, Recurrent C. diff, Finch, Fecal transplant, Fecal microbiota transplant, Finch Therapeutics