Perspectives on the PUNCH CD Trial of a Microbiota-Based Drug Targeted at Recurrent C. diff. Infection

Kathy Tracey, LPN, CCRC, Manager of Clinical Research, Chevy Chase Clinical Research, Chevy Chase, MD; Mary Kay Sobcinski, RN, MHA, Rebiotix Inc., Roseville, MN

Perspectives on the PUNCH CD Trial of a Microbiota-Based Drug Targeted at Recurrent C. difficile Infection

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Society of Gastroenterology Nurses and Associates
May 15–19, 2015, Baltimore, MD

PUNCH CD Study Design

PUNCH CD Study Design

Purpose:

First multi-center study of a next-generation fecal microbiota transplant (FMT) product.

  • Phase 2 open-label study of RBX2660 (microbiota suspension) for recurrent C. diff. infection
  • Multicenter, prospective, study using a single protocol under an FDA Investigational New Drug application
  • Objective: Evaluate the safety and effectiveness of RBX2660