Open Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn Disease Patients Initiating Anti-TNF Therapy
PI: Dr. Kevan Jacobson & Dr. Genelle Lunken
Co-Investigators
Dr. Reza Belaghi, Children’s Hospital of Eastern Ontario
Dr. Benoit Chassaing, Chassaing Laboratory
Dr. Rotem Sigall-Boneh, Wolfson Medical Center, Holon, Israel
Dr. Bruce Vallance, The University of British Columbia
Dr. Eytan Wine, University of Alberta
Purpose
Our primary goal in this randomized controlled trial (RCT) is to compare outcomes of patients with moderate to severely active luminal Crohn’s disease (CD) who start Infliximab as their 1st biologic either alone or in combination with a modified CD exclusion diet (mCDED). Leveraging our Canada-wide pIBD cohort network (CIDsCaNN; CIDsCaNN.ca) and its robust data/sample collection, translational science, and bioinformatics platforms, we will enroll pCD patients with moderate to severe, active luminal CD.
Study Design
The DISPENSE-T study is an open-label, randomized dietary intervention. Participants will be randomized to one of two groups: continuing their usual diet with standard dietary advice (IFX-only group) or starting the modified Crohn’s Disease Exclusion Diet (mCDED + IFX group). Following randomization, each participant will meet with a dietitian and follow the study procedures over a 12-month period
Participating Sites
Dr. Jessica Breton, Université de Montréal
Dr. Eileen Crowley, Western University
Dr. Jennifer DeBruyn, University of Calgary
Dr. Hien Huynh, University of Alberta
Dr. Sally Lawrence, University of British Columbia
Dr. David Mack, University of Ottawa
Dr. Anthony Otley, Dalhousie University
Dr. Rilla Schneider, McGill University
Dr. Mary Sherlock, McMaster University
Dr. Thomas Walters, The Hospital for Sick Children
Targets
Start: Q4 2025
End: TBD