Our Research

Study name: Assessment of Mucosal Biochemical and Clinical Response to Interleukin-12/23 or TNF Inhibitors in Biologic-Naïve Crohn’s Disease

Short title: AMBITION-CD

Sponsor: The Children with Intestinal and Liver Disorders Foundation

Summary: The multi-center Canadian Children IBD Network (CIDsCaNN) brings together investigators across Canada to understand why IBD affects so many Canadian children. We will study children at the time of IBD diagnosis, exploring environmental and exposures; obtaining blood for assessment of genetic risk; and stool for assessment of microorganisms that might be important in the development of IBD. With this prospective cohort study, the goal is to compare outcomes of CD patients with ustekinumab versus anti-TNF as first biologic.

Eligibility: We are recruiting CD patients <17 years old who are anticipated to initiate anti-TNF or ustekinumab as treatment. The duration of CD diagnosis should be ~<18 months and colonoscopic assessment or re-assessment within ~3 months of starting biologic. Those with perianal disease as the primary or co-primary indication for biologic, and those with B2 or B3 disease are to be excluded.

Recruitment status: Ongoing

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Study name: Open-Label Induction and Maintenance Study of Oral CP-690,550 (Tofacitinib) in Children With Moderately to Severely Active Ulcerative Colitis.

Short title: OVATION

Investigational product: Tofacitinib (Xeljanz) 

Sponsor: Pfizer

Summary: This is an open-label Phase 3 study with a screening period of up to 4-weeks, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24- month extension phase for pediatric participants with moderately to severely active UC. This study aims to determine if Tofacitinib is effective and safe in inducing remission in children with moderate to severe UC who have shown an inadequate response or intolerance to at least one of the following prior therapies: oral IV corticosteroids, AZA or 6-MP, or TNF inhibitors or anti-integrin therapy. All participants will receive the equivalent of adult 5mg BID dose, with an option to increase to the equivalent of adult 10mg BID dose if dose escalation criteria are met.

Eligibility: We are currently recruiting 2 - <18 year-old patients weighing at least 10kg with moderately to severely active UC (as defined by a Mayo score of ≥6, with a rectal bleeding score of ≥1 and an endoscopic subscore [Mayo] of ≥2 at screening endoscopy) with a baseline PUCAI of ≥35. Participants should have a clinical diagnosis of UC for at least 12 weeks prior to baseline without history of dysplasia or colon cancer.

BCCH recruitment target: 1-3 patients

Recruitment status: Ongoing 
 

Study name: Implementing a Multimodal Intervention to Improve the Transition of Patients with Inflammatory Bowel Disease from Pediatric to Adult Care 

Short title: Transition Trial/PACE

Intervention: Transition program – includes transition navigator, individualized assessment, skill-building, and e-learning curriculum

Sponsor: Crohn’s and Colitis Canada

Summary: This is an unblinded randomized controlled clinical trial of adolescents with IBD transitioning from pediatric to adult care. The intervention will consist of 4 core components: individualized needs assessment, skill-building, education, and a transition navigator facilitator (nurse practitioner or social worker). Skill-building and e-learning will be tailored based on need and assigned to participants throughout the study by the transition navigator. The control arm will be a standardized version of the typical approach to transition currently used in Canadian IBD centers. The study aims to evaluate the clinical and implementation efficacy of an intervention (consisting of 4 core components) to improve the transition from pediatric to adult care in adolescents and young adults with IBD.

Eligibility: We are recruiting 16-17.5 year-old patients with IBD who have a functional (grade 8 level) English speaking/reading ability and intend to reside in Canada after they transition to adult care. Since e-learning and interactions with transition navigators will be virtual, participants should have access to a smart phone and/or computer.

BCCH recruitment target: 25 patients

Recruitment status: Closed

Study name: Evaluation of the effects of laxative use on microbiota composition and function

Short title: Laxatives and the Microbiota

Sponsor: Grant from CIHR

Investigational product: Laxatives (planned use)

Summary: This study investigates the effects of laxatives on children. Two groups of participants will be enrolled: osmotic laxative and patients with no gastro-intestinal disturbance. The participants enrolled will be patients managed by the physicians at British Columbia Children’s Hospital (BCCH) or patients managed by Dr. Larraine Prisman at the City Pediatric Specialty Group. The goal will be to enroll 62 participants from each group. Controls will be obtained by identifying healthy participants such as siblings, parents and participants that have no gastro-intestinal disturbance and are not taking drugs known to affect the intestinal tract. The primary aim is to evaluate the microbiome differences in laxative-treated pediatric population compared to healthy children and adults.

Eligibility: For cases, we are recruiting patients aged <18 years old who plan to use laxatives, with no previous exposure to laxatives. For controls, we are recruiting children <18 years old or adults with no history of laxative use and no constipation.

BCCH recruitment target: ~62

Recruitment status: Ongoing