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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 : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE May 8, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]
    Sustained clinical cure rate
  • Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]
    Mapped to System Organ Class
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03110133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Sustained clinical cure of CDI by C. difficile subtype [ Time Frame: Week 8 ]
    Proportion of subjects sustaining clinical cure by C. difficile subtype
  • Time to first recurrent CDI episode during the study [ Time Frame: Week 8 and Week 24 ]
    Time to first recurrence of C. difficile
  • Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 24 ]
    Sustained clinical cure rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Infection Recurrence
Intervention  ICMJE
  • Drug: Full Spectrum Microbiota
    Orally administered donor derived microbiota
    Other Name: CP101, FSM
  • Drug: Placebo
    Placebo for CP101
Study Arms  ICMJE
  • Experimental: CP101
    Full Spectrum Microbiota Capsule
    Intervention: Drug: Full Spectrum Microbiota
  • Placebo Comparator: Placebo
    Matching Placebo Capsule
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
240
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zain Kassam, MD, MPH 617-284-6135 PRISM3trial@finchtherapeutics.com
Contact: https://prism3trial.com/
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03110133
Other Study ID Numbers  ICMJE CDI-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Finch Research and Development LLC.
Study Sponsor  ICMJE Finch Research and Development LLC.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Finch Research and Development LLC.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP