title: Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study.
abstract: BACKGROUND
  Managing recurrent Clostridium difficile infection (CDI) presents a significant challenge for clinicians and patients. Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent CDI, yet availability of a standardized, safe, and effective product has been lacking. Our aim in this study was to assess the safety and effectiveness of RBX2660 (microbiota suspension), a commercially prepared FMT drug manufactured using standardized processes and available in a ready-to-use format.
  
  
  METHODS
  Patients with at least 2 recurrent CDI episodes or at least 2 severe episodes resulting in hospitalization were enrolled in a prospective, multicenter open-label study of RBX2660 administered via enema. Intensive surveillance for adverse events (AEs) was conducted daily for 7 days following treatment and then at 30 days, 60 days, 3 months, and 6 months. The primary objective was product-related AEs. A secondary objective was CDI-associated diarrhea resolution at 8 weeks.
  
  
  RESULTS
  Of the 40 patients enrolled at 11 centers in the United States between 15 August 2013 and 16 December 2013, 34 received at least 1 dose of RBX2660 and 31 completed 6-month follow-up. Overall efficacy was 87.1% (16 with 1 dose and 11 with 2 doses). Of 188 reported AEs, diarrhea, flatulence, abdominal pain/cramping, and constipation were most common. The frequency and severity of AEs decreased over time. Twenty serious AEs were reported in 7 patients; none were related to RBX2660 or its administration.
  
  
  CONCLUSIONS
  Among patients with recurrent or severe CDI, administration of RBX2660 via enema appears to be safe and effective.
  
  
  BACKGROUND
  NCT01925417.
authors.affiliation: Division of Infectious Diseases, Mayo Clinic-Arizona, Phoenix.
authors.forename: Robert
authors.initials: R
authors.lastname: Orenstein
authors.affiliation: Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Erik
authors.initials: E
authors.lastname: Dubberke
authors.affiliation: Chevy Chase Clinical Research, Capital Digestive Care, Maryland.
authors.forename: Robert
authors.initials: R
authors.lastname: Hardi
authors.affiliation: Ochsner Clinic, New Orleans, Louisiana.
authors.forename: Arnab
authors.initials: A
authors.lastname: Ray
authors.affiliation: Section of Infectious Diseases and Global Health, University of Chicago Medicine, Illinois.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Mullane
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Darrell S
authors.initials: DS
authors.lastname: Pardi
authors.affiliation: Henry Ford Hospital System, Detroit, Michigan.
authors.forename: Mayur S
authors.initials: MS
authors.lastname: Ramesh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016360:Clostridioides difficile; D003967:Diarrhea / Q000628:therapy; D004733:Enema; D004761:Enterocolitis, Pseudomembranous / Q000628:therapy*; D000069467:Fecal Microbiota Transplantation / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence
keywords: Clostridium difficile; fecal microbiota transplant; microbiome; safety