Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Phase 2

Completed

Conditions: Fecal Microbiota
FMT
Fecal Transplant
C. Diff
Clostridium Difficile Infection
Recurrent Clostridium Difficile Infection
CDI
Recurrent C. Diff
rCDI
C. Difficile

Interventions: Biological: CP101

Registration Number: NCT03497806

Lead Sponsor: Finch Research and Development LLC.

Brief Summary: This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101.

Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 132

Inclusion Criteria

Not provided

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
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
History of total colectomy/ileostomy or bariatric surgery
Planned hospitalization or invasive surgery during the study
Severe acute illness unrelated to CDI

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Dose CP101	CP101	The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication	Up to Week 8	Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Occurence of Treatment Emergent Adverse Events (TEAEs)	Week 8

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication	Up to Week 24	Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.

Trial Locations

Locations (54): Murrieta
🇺🇸
Murrieta, California, United States
Los Angeles
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Los Angeles, California, United States
Shawnee
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Shawnee Mission, Kansas, United States
Toronto
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Toronto, Ontario, Canada
Burr Ridge
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Burr Ridge, Illinois, United States
Grafton
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Grafton, Wisconsin, United States
Evanston
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Evanston, Illinois, United States
Royal Oak
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Royal Oak, Michigan, United States
Kinston
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Kinston, North Carolina, United States
Chicago
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Chicago, Illinois, United States
Jacksonville
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Jacksonville, Florida, United States
Bronx
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Bronx, New York, United States
Ogden
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Ogden, Utah, United States
Pinellas Park
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Pinellas Park, Florida, United States
West Des Moines
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West Des Moines, Iowa, United States
Poland
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Poland, Ohio, United States
Boston
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Boston, Massachusetts, United States
Indianapolis
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Indianapolis, Indiana, United States
San Diego
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San Diego, California, United States
Cincinnati
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Cincinnati, Ohio, United States
Oakland
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Oakland, California, United States
Naples
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Naples, Florida, United States
Idaho Falls
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Idaho Falls, Idaho, United States
Atlanta
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Atlanta, Georgia, United States
Maywood
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Maywood, Illinois, United States
St. Paul
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Saint Paul, Minnesota, United States
Pinehurst
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Pinehurst, North Carolina, United States
Providence
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Providence, Rhode Island, United States
Annandale
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Annandale, Virginia, United States
Charlottesville
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Charlottesville, Virginia, United States
Halifax
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Halifax, Nova Scotia, Canada
London
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London, Ontario, Canada
New York
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New York, New York, United States
Hamden
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Hamden, Connecticut, United States
Butte
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Butte, Montana, United States
Scottsdale
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Scottsdale, Arizona, United States
Washington DC
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Washington, District of Columbia, United States
Bridgeport
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Bridgeport, Connecticut, United States
Morristown
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Morristown, New Jersey, United States
Calgary
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Calgary, Alberta, Canada
Seattle
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Seattle, Washington, United States
Winston-Salem
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Winston-Salem, North Carolina, United States
Nashville
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Nashville, Tennessee, United States
San Francisco
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San Francisco, California, United States
Aurora
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Aurora, Colorado, United States
Tampa
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Tampa, Florida, United States
San Antonio
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San Antonio, Texas, United States
Detroit
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Detroit, Michigan, United States
Rochester
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Rochester, Minnesota, United States
Portland
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Portland, Oregon, United States
Salt Lake City
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Salt Lake City, Utah, United States
Chapel Hill
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Chapel Hill, North Carolina, United States
New Orleans
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New Orleans, Louisiana, United States
Somers Point
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Somers Point, New Jersey, United States