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



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:May 8, 2017
End Date:November 2019
Contact:Ulrich Thienel, MD
Email:PRISM3trial@finchtherapeutics.com
Phone:617-284-6135

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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

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.

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).

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
We found this trial at
55
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West Des Moines, Iowa 50265
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Annandale, Virginia 22003
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13123 East 16th Avenue
Aurora, Colorado 80045
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Baltimore, Maryland
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Birmingham, Alabama 35205
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Boston, Massachusetts 02115
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Bridgeport, Connecticut 06610
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Burr Ridge, Illinois 60527
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Butte, Montana 59701
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Calgary, Alberta
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Chapel Hill, North Carolina
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Charlottesville, Virginia 22908
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Chicago, Illinois 60061
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Cincinnati, Ohio 45219
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Detroit, Michigan
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Evanston, Illinois 60201
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Grafton, Wisconsin 53024
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Hamden, Connecticut 06518
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46260
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Jacksonville, Florida
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Kinston, North Carolina 28501
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Lexington, Kentucky 40536
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Los Angeles, California 90036
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Maywood, Illinois 60153
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Morristown, New Jersey
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Murrieta, California 92563
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Naples, Florida 34102
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3200 West End Avenue
Nashville, Tennessee 37203
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New Bern, North Carolina 28562
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New Orleans, Louisiana 70115
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New York, New York 10001
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Oakland, California 94607
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Ogden, Utah 84403
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Pinehurst, North Carolina 28374
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Pinellas Park, Florida 33781
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Poland, Ohio 44514
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Portland, Oregon 97210
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Providence, Rhode Island 02904
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Rochester, Minnesota 55902
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Royal Oak, Michigan 48073
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Saint Paul, Minnesota 55130
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Salt Lake City, Utah 84124
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San Antonio, Texas 78229
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San Francisco, California 94121
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Scottsdale, Arizona 85258
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Seattle, Washington
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Shawnee Mission, Kansas 66128
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Somers Point, New Jersey 08244
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Tampa, Florida 33603
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Washington, District of Columbia
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Winston-Salem, North Carolina 27103
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