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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-009490
    NCT ID: NCT03110133
    Sponsor Protocol Number: CDI-001

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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 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
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Orenstein, D.O.

Open for enrollment

Contact information:

Vy Nguyen CCRP

(480)342-1328

Nguyen.Vy@mayo.edu