Authors
Christine H Lee, Theodore Steiner, Elaine O Petrof, Marek Smieja, Diane Roscoe, Anouf Nematallah, J Scott Weese, Stephen Collins, Paul Moayyedi, Mark Crowther, Mark J Ropeleski, Padman Jayaratne, David Higgins, Yingfu Li, Neil V Rau, Peter T Kim
Publication date
2016/1/12
Journal
Jama
Volume
315
Issue
2
Pages
142-149
Publisher
American Medical Association
Description
Importance
Clostridium difficileinfection (CDI) is a major burden in health care and community settings. CDI recurrence is of particular concern because of limited treatment options and associated clinical and infection control issues. Fecal microbiota transplantation (FMT) is a promising, but not readily available, intervention.
Objective
To determine whether frozen-and-thawed (frozen, experimental) FMT is noninferior to fresh (standard) FMT in terms of clinical efficacy among patients with recurrent or refractory CDI and to assess the safety of both types of FMT.
Design, Setting, and Participants
Randomized, double-blind, noninferiority trial enrolling 232 adults with recurrent or refractory CDI, conducted between July 2012 and September 2014 at 6 academic medical centers in Canada.
Interventions
Patients were randomly allocated to receive frozen (n = 114) or fresh (n = 118) FMT via enema.
Main Outcomes and …
Scholar articles
CH Lee, T Steiner, EO Petrof, M Smieja, D Roscoe… - Jama, 2016