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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 : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

Study Description
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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).

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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


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

  Show 56 Study Locations
Sponsors and Collaborators
Finch Research and Development LLC.
More Information
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Additional Information:
trial website  This link exits the ClinicalTrials.gov site

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: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Infection
Communicable Diseases
Recurrence
Disease Attributes
Pathologic Processes