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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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: CP101
Full Spectrum Microbiota Capsule
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Drug: Full Spectrum Microbiota
Orally administered donor derived microbiota
Other Name: CP101, FSM |
Placebo Comparator: Placebo
Matching Placebo Capsule
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Drug: Placebo
Placebo for CP101 |
- Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]Sustained clinical cure rate
- Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]Mapped to System Organ Class
- Sustained clinical cure of CDI by C. difficile subtype [ Time Frame: Week 8 ]Proportion of subjects sustaining clinical cure by C. difficile subtype
- Time to first recurrent CDI episode during the study [ Time Frame: Week 8 and Week 24 ]Time to first recurrence of C. difficile
- Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 24 ]Sustained clinical cure rate

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Responsible Party: | Finch Research and Development LLC. |
ClinicalTrials.gov Identifier: | NCT03110133 |
Other Study ID Numbers: |
CDI-001 |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Clostridium Difficile Infection CP101 Crestovo FMT CDI C. difficile C. diff Recurrent Clostridium Difficile Infection |
Recurrent C. diff Recurrent CDI Finch Fecal transplant Fecal microbiota transplant rCDI Finch Therapeutics |
Infections Communicable Diseases Clostridium Infections Enterocolitis, Pseudomembranous Recurrence Disease Attributes Pathologic Processes Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Enterocolitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |