Clinical trial NCT03110133: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection Recurrence
Keywords: 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
Lead sponsor: Finch Research and Development LLC.
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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

Primary outcomes:
measure: Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
timeFrame: Week 8
measure: Number of Participants With Occurrence of Treatment Emergent Adverse Events
timeFrame: Week 8
Secondary outcomes:
measure: Time to First Recurrent CDI Episode During the Study
timeFrame: Week 8
measure: Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
timeFrame: Week 24
measure: Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles
state: California
city: Murrieta
country: United States
facility: Murrieta
state: California
city: Oakland
country: United States
facility: Oakland
state: California
city: San Diego
country: United States
facility: San Diego
state: California
city: San Francisco
country: United States
facility: San Francisco
state: California
city: Aurora
country: United States
facility: Aurora
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport
state: Connecticut
city: Hamden
country: United States
facility: Hamden
state: Connecticut
city: Washington
country: United States
facility: Washington DC
state: District of Columbia
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Naples
country: United States
facility: Naples
state: Florida
city: Pinellas Park
country: United States
facility: Pinellas Park
state: Florida
city: Tampa
country: United States
facility: Tampa
state: Florida
city: Atlanta
country: United States
facility: Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls
state: Idaho
city: Burr Ridge
country: United States
facility: Burr Ridge
state: Illinois
city: Chicago
country: United States
facility: Chicago
state: Illinois
city: Evanston
country: United States
facility: Evanston
state: Illinois
city: Maywood
country: United States
facility: Maywood
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis
state: Indiana
city: West Des Moines
country: United States
facility: West Des Moines
state: Iowa
city: Shawnee Mission
country: United States
facility: Shawnee
state: Kansas
city: New Orleans
country: United States
facility: New Orleans
state: Louisiana
city: Boston
country: United States
facility: Boston
state: Massachusetts
city: Detroit
country: United States
facility: Detroit
state: Michigan
city: Royal Oak
country: United States
facility: Royal Oak
state: Michigan
city: Rochester
country: United States
facility: Rochester
state: Minnesota
city: Saint Paul
country: United States
facility: St. Paul
state: Minnesota
city: Butte
country: United States
facility: Butte
state: Montana
city: Morristown
country: United States
facility: Morristown
state: New Jersey
city: Somers Point
country: United States
facility: Somers Point
state: New Jersey
city: Bronx
country: United States
facility: Bronx
state: New York
city: New York
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill
state: North Carolina
city: Kinston
country: United States
facility: Kinston
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati
state: Ohio
city: Poland
country: United States
facility: Poland
state: Ohio
city: Portland
country: United States
facility: Portland
state: Oregon
city: Lancaster
country: United States
facility: Lancaster
state: Pennsylvania
city: Providence
country: United States
facility: Providence
state: Rhode Island
city: Nashville
country: United States
facility: Nashville
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio
state: Texas
city: Ogden
country: United States
facility: Ogden
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake City
state: Utah
city: Annandale
country: United States
facility: Annandale
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville
state: Virginia
city: Seattle
country: United States
facility: Seattle
state: Washington
city: Grafton
country: United States
facility: Grafton
state: Wisconsin
city: Calgary
country: Canada
facility: Calgary
state: Alberta
city: Halifax
country: Canada
facility: Halifax
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto
state: Ontario
city: Toronto
country: Canada
facility: Toronto
state: Ontario
Study officials:
References: