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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 : Recruiting
First Posted : April 12, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

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




Primary Outcome Measures :
  1. Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]
    Sustained clinical cure rate

  2. Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]
    Mapped to System Organ Class


Secondary Outcome Measures :
  1. Sustained clinical cure of CDI by C. difficile subtype [ Time Frame: Week 8 ]
    Proportion of subjects sustaining clinical cure by C. difficile subtype

  2. Time to first recurrent CDI episode during the study [ Time Frame: Week 8 and Week 24 ]
    Time to first recurrence of C. difficile

  3. Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 24 ]
    Sustained clinical cure rate



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Ulrich Thienel, MD 617-284-6135 PRISM3trial@finchtherapeutics.com
Contact: https://prism3trial.com/

  Hide Study Locations
Locations
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United States, Alabama
Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Scottsdale Recruiting
Scottsdale, Arizona, United States, 85054
United States, California
Los Angeles Recruiting
Los Angeles, California, United States, 90095
Murrieta Recruiting
Murrieta, California, United States, 92563
Oakland Not yet recruiting
Oakland, California, United States, 94705
San Diego Recruiting
San Diego, California, United States, 92123
San Francisco Recruiting
San Francisco, California, United States, 94115
United States, Colorado
Aurora Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Bridgeport Recruiting
Bridgeport, Connecticut, United States, 06610
Hamden Recruiting
Hamden, Connecticut, United States, 06518
United States, District of Columbia
Washington DC Recruiting
Washington, District of Columbia, United States, 20422
United States, Florida
Jacksonville Recruiting
Jacksonville, Florida, United States, 32256
Naples Recruiting
Naples, Florida, United States, 34102
Pinellas Park Recruiting
Pinellas Park, Florida, United States, 33781
Tampa Recruiting
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta Recruiting
Atlanta, Georgia, United States, 30322
United States, Idaho
Idaho Falls Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Burr Ridge Recruiting
Burr Ridge, Illinois, United States, 60527
Chicago Recruiting
Chicago, Illinois, United States, 60637
Evanston Recruiting
Evanston, Illinois, United States, 60201
Maywood Recruiting
Maywood, Illinois, United States, 60153
United States, Indiana
Indianapolis Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
West Des Moines Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Shawnee Recruiting
Shawnee Mission, Kansas, United States, 66217
United States, Kentucky
Lexington Recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
New Orleans Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore Recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston Recruiting
Boston, Massachusetts, United States, 02114
Boston Recruiting
Boston, Massachusetts, United States, 02115
Boston Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit Recruiting
Detroit, Michigan, United States, 48202
Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Rochester Recruiting
Rochester, Minnesota, United States, 55905
St. Paul Recruiting
Saint Paul, Minnesota, United States, 55130
United States, Montana
Butte Recruiting
Butte, Montana, United States, 59701
United States, New Jersey
Morristown Recruiting
Morristown, New Jersey, United States, 07960
Somers Point Recruiting
Somers Point, New Jersey, United States, 08244
United States, New York
Bronx Recruiting
Bronx, New York, United States, 10467
New York Recruiting
New York, New York, United States, 10016
New York Recruiting
New York, New York, United States, 10021
New York Recruiting
New York, New York, United States, 10029
United States, North Carolina
Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Kinston Recruiting
Kinston, North Carolina, United States, 28501
New Bern Withdrawn
New Bern, North Carolina, United States, 28562
Pinehurst Recruiting
Pinehurst, North Carolina, United States, 28374
Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Poland Recruiting
Poland, Ohio, United States, 44514
United States, Oregon
Portland Recruiting
Portland, Oregon, United States, 97239
United States, Rhode Island
Providence Recruiting
Providence, Rhode Island, United States, 02904
United States, Tennessee
Nashville Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
San Antonio Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Ogden Recruiting
Ogden, Utah, United States, 84403
Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84124
United States, Virginia
Annandale Recruiting
Annandale, Virginia, United States, 22003
Charlottesville Recruiting
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle Recruiting
Seattle, Washington, United States, 98101
United States, Wisconsin
Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Canada, Alberta
Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Canada, Nova Scotia
Halifax Not yet recruiting
Halifax, Nova Scotia, Canada, B3H4C5
Canada, Ontario
Oshawa Not yet recruiting
Oshawa, Ontario, Canada, B3-414
Toronto Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Finch Research and Development LLC.

Additional Information:
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Responsible Party: Finch Research and Development LLC.
ClinicalTrials.gov Identifier: NCT03110133     History of Changes
Other Study ID Numbers: CDI-001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
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
Open Biome
Openbiome
Fecal microbiota transplant
rCDI

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Recurrence
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections