Study concept and design: Lee, Petrof, Smieja, Roscoe, Collins, Moayyedi, Higgins, Kim.
Acquisition, analysis, or interpretation of data: Lee, Steiner, Petrof, Smieja, Nematallah, Weese, Moayyedi, Crowther, Ropeleski, Jayaratne, Li, Rau, Kim.
Drafting of the manuscript: Lee, Steiner, Petrof, Smieja, Higgins, Kim.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Smieja, Kim.
Obtained funding: Lee, Petrof, Crowther, Higgins, Kim.
Administrative, technical, or material support: Lee, Petrof, Smieja, Roscoe, Moayyedi, Crowther, Ropeleski, Jayaratne, Higgins, Li, Kim.
Study supervision: Lee, Petrof, Smieja, Roscoe, Higgins, Kim.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Lee reported participating in clinical trials for ViroPharma, Actelion, Cubist, and Merck and serving as a member of the advisory boards for Rebiotix and Merck. Dr Steiner reported receiving consulting fees and an unrestricted grant from Cubist, consulting fees and a phase 3 trial contract from Merck Canada, and a phase 3 trial contract from Sanofi Pasteur; additionally, his institution was recently approved as a site for a phase 2b randomized clinical trial of frozen stool product with Rebiotix. Dr Petrof reported holding a patent for synthetic stool formation. Dr Crowther reported receiving grants from the Heart and Stroke Foundation of Ontario, Leo Pharma, and Bayer, as well as funding for educational materials from Alexion, Ortho Clinical Diagnostics, BMS-Pfizer Alliance, Leo Pharma, Bayer, Celgene, Shire, and CSL Behring. Dr Kim reported serving as a member of the advisory board for Rebiotix. No other authors reported disclosures.
Funding/Support: The study was funded by Physicians Services Incorporated, Natural Sciences and Engineering Council, National Science Foundation, and Gastrointestinal Diseases Research Unit, Kingston General Hospital, Ontario.
Role of the Funders/Sponsors: None of the external funders/sponsors had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: The data monitoring committee (DMC) for this study comprised Fiona Smaill, MB, Shariq Haider, MD, and Keith Tsoi, MD (all of McMaster University, Hamilton, Ontario); and Gerald Evans, MD (Queens University, Kingston, Ontario). Dale Gerding, MD (Hines Veterans Affairs Hospital, Hines, Illinois), provided comments. Editorial support was provided by Ashfield Healthcare and Michael Shaw, PhD (MScript Ltd, Hove, United Kingdom, funded by PSI). The members of the DMC and Dr Gerding received no compensation for their contributions.