Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3)

Overview

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 Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3)

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Orenstein, D.O.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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