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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Crestovo LLC
Sponsor:
Information provided by (Responsible Party):
Crestovo LLC
ClinicalTrials.gov Identifier:
NCT03110133
First received: April 3, 2017
Last updated: August 24, 2017
Last verified: August 2017
  Purpose
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

Condition Intervention Phase
Clostridium Difficile Infection Recurrence Drug: Full Spectrum Microbiota Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Crestovo LLC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 240
Actual Study Start Date: May 8, 2017
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose
High Dose Full Spectrum Microbiota
Drug: Full Spectrum Microbiota
Orally administered donor derived microbiota
Other Name: CP101, FSM
Experimental: Low Dose
Low dose Full Spectrum Microbiota
Drug: Full Spectrum Microbiota
Orally administered donor derived microbiota
Other Name: CP101, FSM
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo for CP101

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent
  • Men or women age 18 to 85 years of age, inclusive
  • Current diagnosis of a recurrence of non-severe, non-complicated CDI
  • Subject has a clinical response to a standard course of oral vancomycin therapy to treat the current episode of recurrent CDI

Exclusion Criteria:

  • Pregnant, breast-feeding, or considering becoming pregnant during the study
  • Current administration of a long-term vancomycin regimen (step reduction or pulse)
  • Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
  • Any prior diagnosis of irritable bowel syndrome (IBS), or currently meets Rome III criteria for IBS.
  • Systemic chemotherapy for the treatment of cancer during the 60 days prior to consent or planned during the study
  • Prior fecal transplant for any condition, regardless of route of administration
  • Presence of ileostomy or colostomy, or history of prior gastric resection or significant colon resection
  • Planned hospitalization or invasive surgery during the study
  • Severe acute illness unrelated to CDI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03110133

Contacts
Contact: Kirk Taylor, MD 617-315-2138 trialinfo@crestovo.com

  Show 43 Study Locations
Sponsors and Collaborators
Crestovo LLC
  More Information

Responsible Party: Crestovo LLC
ClinicalTrials.gov Identifier: NCT03110133     History of Changes
Other Study ID Numbers: CDI-001
Study First Received: April 3, 2017
Last Updated: August 24, 2017
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 Crestovo LLC:
Clostridium Difficile Infection
CP101
Crestovo
FMT
CDI
C. difficile

Additional relevant MeSH terms:
Infection
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017