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

Primary Purpose

Clostridium Difficile Infection Recurrence

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Full Spectrum Microbiota
Placebo
Sponsored by
Finch Research and Development LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection Recurrence focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scottsdale
  • Los Angeles
  • Murrieta
  • Oakland
  • San Diego
  • San Francisco
  • Aurora
  • Bridgeport
  • Hamden
  • Washington DC
  • Jacksonville
  • Naples
  • Pinellas Park
  • Tampa
  • Atlanta
  • Idaho Falls
  • Burr Ridge
  • Chicago
  • Evanston
  • Maywood
  • Indianapolis
  • West Des Moines
  • Shawnee
  • New Orleans
  • Boston
  • Detroit
  • Royal Oak
  • Rochester
  • St. Paul
  • Butte
  • Morristown
  • Somers Point
  • Bronx
  • New York
  • New York
  • New York
  • Chapel Hill
  • Kinston
  • Pinehurst
  • Winston-Salem
  • Winston-Salem
  • Cincinnati
  • Poland
  • Portland
  • Lancaster
  • Providence
  • Nashville
  • San Antonio
  • Ogden
  • Salt Lake City
  • Annandale
  • Charlottesville
  • Seattle
  • Grafton
  • Calgary
  • Halifax
  • Toronto
  • Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CP101

Placebo

Arm Description

Full Spectrum Microbiota Capsule

Matching Placebo Capsule

Outcomes

Primary Outcome Measures

Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Defined in the protocol as sustained clinical cure
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)

Secondary Outcome Measures

Time to First Recurrent CDI Episode During the Study
The number of days between IP administration and the first C. Difficile recurrence
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Defined in the protocol as sustained clinical cure
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
NAP1 is the North American Pulse-field C. difficile subtype.

Full Information

First Posted
April 3, 2017
Last Updated
September 6, 2022
Sponsor
Finch Research and Development LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT03110133
Brief Title
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Acronym
PRISM3
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finch Research and Development LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP101
Arm Type
Experimental
Arm Description
Full Spectrum Microbiota Capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo Capsule
Intervention Type
Drug
Intervention Name(s)
Full Spectrum Microbiota
Other Intervention Name(s)
CP101, FSM
Intervention Description
Orally administered donor derived microbiota
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for CP101
Primary Outcome Measure Information:
Title
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Description
Defined in the protocol as sustained clinical cure
Time Frame
Week 8
Title
Number of Participants With Occurrence of Treatment Emergent Adverse Events
Description
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)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Time to First Recurrent CDI Episode During the Study
Description
The number of days between IP administration and the first C. Difficile recurrence
Time Frame
Week 8
Title
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Description
Defined in the protocol as sustained clinical cure
Time Frame
Week 24
Title
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
Description
NAP1 is the North American Pulse-field C. difficile subtype.
Time Frame
Up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Murrieta
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Bridgeport
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Hamden
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pinellas Park
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Idaho Falls
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Burr Ridge
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Maywood
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Shawnee
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States
Facility Name
New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Paul
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
Butte
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Morristown
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Somers Point
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Pinehurst
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Poland
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ogden
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Annandale
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H4C5
Country
Canada
Facility Name
Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://prism3trial.com/
Description
trial website

Learn more about this trial

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

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