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

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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection Recurrence
• Intervention / Treatment: Drug: Placebo; Drug: Full Spectrum Microbiota

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: Interventional
• Enrollment (Actual): 206
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H4C5
      • Halifax
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Scottsdale
  • California
    • Los Angeles, California, United States, 90095
      • Los Angeles
    • Murrieta, California, United States, 92563
      • Murrieta
    • Oakland, California, United States, 94705
      • Oakland
    • San Diego, California, United States, 92123
      • San Diego
    • San Francisco, California, United States, 94115
      • San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Aurora
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport
    • Hamden, Connecticut, United States, 06518
      • Hamden
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Jacksonville
    • Naples, Florida, United States, 34102
      • Naples
    • Pinellas Park, Florida, United States, 33781
      • Pinellas Park
    • Tampa, Florida, United States, 33614
      • Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Idaho Falls
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Burr Ridge
    • Chicago, Illinois, United States, 60637
      • Chicago
    • Evanston, Illinois, United States, 60201
      • Evanston
    • Maywood, Illinois, United States, 60153
      • Maywood
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indianapolis
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • West Des Moines
  • Kansas
    • Shawnee Mission, Kansas, United States, 66217
      • Shawnee
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Detroit
    • Royal Oak, Michigan, United States, 48073
      • Royal Oak
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Rochester
    • Saint Paul, Minnesota, United States, 55130
      • St. Paul
  • Montana
    • Butte, Montana, United States, 59701
      • Butte
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown
    • Somers Point, New Jersey, United States, 08244
      • Somers Point
  • New York
    • Bronx, New York, United States, 10467
      • Bronx
    • New York, New York, United States, 10016
      • New York
    • New York, New York, United States, 10021
      • New York
    • New York, New York, United States, 10029
      • New York
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Chapel Hill
    • Kinston, North Carolina, United States, 28501
      • Kinston
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst
    • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem
    • Winston-Salem, North Carolina, United States, 27157
      • Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati
    • Poland, Ohio, United States, 44514
      • Poland
  • Oregon
    • Portland, Oregon, United States, 97239
      • Portland
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Providence
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Nashville
  • Texas
    • San Antonio, Texas, United States, 78229
      • San Antonio
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden
    • Salt Lake City, Utah, United States, 84124
      • Salt Lake City
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Annandale
    • Charlottesville, Virginia, United States, 22908
      • Charlottesville
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle
  • Wisconsin
    • Grafton, Wisconsin, United States, 53024
      • Grafton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CP101; Full Spectrum Microbiota Capsule	Drug: Full Spectrum Microbiota; Orally administered donor derived microbiota; Other Names: CP101, FSM
PLACEBO_COMPARATOR: Placebo; Matching Placebo Capsule	Drug: Placebo; Placebo for CP101

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Finch Research and Development LLC.

Publications and helpful links

Helpful Links

• trial website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 8, 2017
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): June 18, 2020

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: FMT; CDI; Clostridium Difficile Infection; Fecal transplant; Fecal microbiota transplant; C. difficile; CP101; Crestovo; C. diff; Recurrent Clostridium Difficile Infection; Recurrent C. diff; Recurrent CDI; Finch; rCDI; Finch Therapeutics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: CDI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No