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Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (PRISM3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110133
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : July 6, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Recurrence Drug: Full Spectrum Microbiota Drug: Placebo Phase 2

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 Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: CP101
Full Spectrum Microbiota Capsule
 Drug: Full Spectrum Microbiota
Orally administered donor derived microbiota
Other Name: CP101, FSM
Placebo Comparator: Placebo
Matching Placebo Capsule
 Drug: Placebo
Placebo for CP101


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Show Show 58 study locations
Sponsors and Collaborators
Finch Research and Development LLC.
  Study Documents (Full-Text)

Documents provided by Finch Research and Development LLC.:
Study Protocol  [PDF] March 1, 2019
Statistical Analysis Plan  [PDF] April 12, 2021

More Information
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Additional Information:

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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
Results First Posted: July 6, 2022
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Finch Research and Development LLC.:
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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Recurrence
Disease Attributes
 Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses