A prospective, multicenter, randomized controlled trial comparing fecal microbiota transplantation (FMT) to placebo in the treatment of active pouchitis

The association of food intake and relapse of Inflammatory Bowel Diseases (The FOOD-IBD study)

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The primary aim of this study is to determine if individuals with IBD who are in clinical remission and have a diet higher in ultra-processed foods have an increased risk of disease relapse compared to those with a diet lower in ultra-processed foods.

Bowel preparation for colonoscopy among individuals with IBD: A randomized controlled trial

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The primary aim is to determine the overall preferred Bowel prep laxative agent for individuals with IBD preparing for colonoscopy and to provide physicians and patients with contemporary data on the efficacy and tolerability of Bowel prep laxatives for those with IBD undergoing colonoscopy.

Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission

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The objective of the study is to compare the effectiveness, burden, and safety of switching to an alternative therapy for achieving endoscopic remission versus continuing the current treatment in asymptomatic patients with inflammatory bowel disease (IBD) and ongoing endoscopic inflammation, while also identifying heterogeneity of treatment effects through preplanned subgroup analyses.

Comparison of medical RESCUE strategies for patients with steroid-refractory acute severe Ulcerative Colitis: an open-label randomized controlled trial.

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The primary objective of this study is to evaluate whether treatment success in patients with Acute Severe Ulcerative Colitis who are treated with strategy U (Upadacitinib) is non-inferior to strategy C (conventional rescue therapy), after 16 weeks of initiating therapeutic management.

This is an open label study with all UC patients receiving FMT.

Primary objectives: Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

Maintenance of remission of UC after three years in those who achieve initial remission with FMT.  This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy.

Real-World Effectiveness and Safety of Upadacitinib for Achieving Endoscopic Remission in Moderate-to-Severely Active Ulcerative Colitis: A Prospective, Multicenter Canadian IBD Research Consortium Cohort Study (REMIT-UC-UPA)

The primary objective of this study is to evaluate the cumulative proportion of UC patients achieving endoscopic remission (defined by MES=0) within 12 months of initiating upadacitinib therapy.

A Randomized, Double-blind, Placebo-Controlled Phase 3b Study to Evaluate the Short and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease

The Primary Objective is to evaluate whether dual-targeted therapy (DTT; vedolizumab and upadacitinib) during induction improves clinical and endoscopic outcomes by Week 12, compared with vedolizumab monotherapy, in participants with moderately to severely active Crohn’s disease (CD).

Characterization of Early Response to Vedolizumab and Ustekinumab in Participants with Crohn’s Disease Using Patient-Reported Outcome Measures (VOICE): A Prospective Observational Study

The primary objective is to assess the onset of biologic therapy on pain interference and multiple quality of life (QOL) and functioning domains. Evaluate the efficacy of therapy in improving pain interference, fatigue, anxiety, depression, sleep disturbance, physical function, and social participation through Week 52. Analyze early patient-reported symptom changes through Week 14. Evaluate the association between PRO-2 and PROMIS domains. Assess the efficacy of therapy for symptom resolution, fecal urgency improvement, and health-related QOL through Week 52 while examining the durability of symptom improvement. Determine steroid-free PRO-2 clinical remission at Weeks 22 and 52, and analyze the effects of therapy by participant subgroups.

Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants with Permanent Ileostomy

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The primary aim is to develop a novel O-PRO and O-EI outcome measure for participants with CD and permanent ileostomy.