INVESTIGATOR-INITIATED RESEARCH PROJECTS

Investigator-initiated clinical trial: A trial where the academic investigator generates the research question(s) and study design, controls the content and conduct of the research protocol and has ultimate and final responsibility for making changes to the same protocol, and for analyzing data and reporting results. The Investigator and institution holds the intellectual property to the project and its results. Investigator-initiated protocols are not defined by the source of funding

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INDUSTRY-INITIATED CLINICAL TRIALS

Industry-initiated clinical trial is a trial designed and funded by an industry organization such as a pharmaceutical company, biotech, or other entity that has contracted with a faculty member to conduct a clinical trial that involves an intervention with, or observation of, a disease or biomedical condition, or a registry related to a disease or biomedical condition. For most industry-sponsored clinical trials, the industry organization designs the study and owns the protocol.

For more information about our ongoing industry-sponsored clinical trials, please click here


Quality Improvement in IBD

Systematic, structured, sustainable assessment of quality of health care provided to IBD patients in the IBD Unit at the University of Alberta

The aim of this project is to continuously assess and monitor the full spectrum of process and outcome quality indicators. We evaluate how these quality indicators differ between patients continuously monitored by our IBD specialists and those who receive IBD care outside of our IBD Unit.

We also explore associations between patients' demographic, clinical, endoscopic, and medication history' characteristics and various process and outcome quality indicators. We also would like to evaluate the age-gender incidence and prevalence rates of IBD in Alberta since early 2000s and their associations with hospitalizations, ED visits, surgical rates, mortality, and other health and health care outcomes.

 

PI: Dr. Karen Kroeker

Contacts:

Dr. Ellina Lytvyak     lytvyak@ualberta.ca

Reed Sutton reed.gastro@ualberta.ca

 

Adherence to Evidence–Based Guidelines and Best Practices for IBD Flare Management and Corticosteroid Administration Among IBD- and Non-IBD-Practitioners in Ambulatory Setting: A Retrospective Study

This is a retrospective, cross-sectional, single centre, cohort study that is being carried out using the demographic, clinical, prescribing, and health data from the Electronic Medical Records (EMRs) and administrative databases of patients. This study is a part of the PACE project.

In our study, we determine the extent to which IBD specialists implement published evidence–based guidelines and best practices regarding the prescribing of corticosteroids for the induction and maintenance of remission in IBD. We also assess the patient and health care outcomes, and associated costs in relation to the corticosteroids prescribing practices.

 

PI: Dr. Karen Kroeker

Contact: Reed Sutton     reed.gastro@ualberta.ca

 

In the IBD Unit at the University of Alberta Hospital in collaboration with University of Calgary IBD specialists, we designed, developed and validated a set of the IBD Clinical Care Pathways (CCPs). One of the CCPs, the “Flare Management” was designed as a decision making algorithm and includes complains and history assessment, timelines and laboratory/diagnostic imaging investigations. The “Flare Management” CCP was embedded into the Electronic Medical Records (EMR) system in a form of a smartset offering a streamlined process of managing IBD Flare and harmonization of various clinical and administrative components.

 The aim of this study is to assess the effect of EMR-integrated “Flare Management” CCP on IBD specialists’ practice, continuity of IBD care, patients’ health and health care outcomes, and health care costs.

 

Contact: Reed Sutton     reed.gastro@ualberta.ca

PI: Dr. Karen Kroeker


Studies on IBD

MAGIC (IMAGINE Cohort Study)

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MAGIC is IMAGINE’s main cohort study. With the goal of recruiting 8,000 subjects, this project will study how three important variables (genes, diet and mental health) impact the gut microbiome in persons with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) and in turn how together they impact the disease course. More information can be found here: http://imaginespor.com/magic-main-cohort-study/.

PI: Dr. Karen Madsen

Contact: Lindsy Ambrosio (ambrosio@ualberta.ca)

 

A Survey for the Use of Prebiotics, Probiotics and Dietary Fibre Supplements in IBD

Probiotics, prebiotics and dietary fibre supplements are novel alternative therapies in the treatment of inflammatory bowel disease (IBD).   These agents help to alter the microbes in the gut and help offset levels of inflammation.  In addition, they are safer and increasingly cost-effective in comparison to pharmaceutical therapies used for IBD.  However, little is known regarding usage patterns and information on knowledge of these products in patients with inflammatory bowel disease.

The aim of this study is to assess the utilization and knowledge of prebiotics, probiotics and dietary fibre supplements in patients with IBD through a survey questionnaire, in order to optimize treatment strategies and understand reasons for use and disuse.  A prospective chart review to correlate disease phenotype and progression will be conducted post-survey completion.

 

PI: Dr. Leo Dieleman

Contact: ucprebio@ualberta.ca

Stress Reduction in IBD

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This study will use an online stress reduction program to help people with inflammatory bowel disease (IBD) identify and manage stressors. More information can be found at: www.wellnesstoolbox.ca/intro

PI: Dr. Puneeta Tandon

Contact: talktous@wellnesstoolbox.ca


Studies on Ulcerative colitis

Double blind Placebo-controlled Trial for the Prevention of Ulcerative Colitis Relapses Using the Prebiotic Combination Synergy-1

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Prebiotics are sugars and fibers that can be found in several vegetables, such as onions, leeks, asparagus and garlic. These food supplements are known to promote the growth of protective bacteria (also known as probiotics) in the large bowel.  Such probiotics have also been shown to prevent and even treat ulcerative colitis.  Instead of ingesting large quantities of live probiotic bacteria this current study will supplement the diet with the prebiotic fibers inulin plus oligofructose (Synergy-1) to stimulate the growth and function of those protective bacteria that are already present in the intestines.

This study is a randomized placebo-controlled trial that includes a 6 month interventional period with patients randomized to either the prebiotic Synergy-1 (inulin + oligofructose) or the control maltodextrin and a 6 month post-treatment observational period.  The aim of this study is to assess the frequency of relapse of ulcerative colitis using prebiotic fibres in patients that are in clinical remission.

 

PI: Dr. Leo Dieleman

Contact: Rosica Valcheva (valcheva@ualberta.ca), Oggy (ucprebio@ualberta.ca)

Assessing the Effectiveness of a Remote Patient Monitoring Protocol in Improving Patient Care

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The treatment of UC involves several different therapies depending on disease severity. When patients achieve disease remission, long-term maintenance therapy is often used in order to prevent a disease flare.  However, when patients are not experiencing symptoms, they are often lost to follow-up and do not have regular visits with their gastroenterologist. This can be problematic because symptoms have a poor correlation with disease activity in many instances, and do not always signify mucosal healing. 

Recently, our centre has initiated a clinical outreach protocol to remotely monitor the disease activity of UC patients who have not been seen by their gastroenterologist in over 6 months. The protocol involves patients completing disease activity and medication questionnaires, routine blood work, and a fecal calprotectin stool test. Our study aims to assess physician response to the protocol and determining if the protocol led to a change in patient care.

 

PI: Dr. Brendan Halloran

Contact: Candace Beilman (cbeilman@ualberta.ca)


Studies on Crohn's disease

A prospective, multicenter, randomized controlled trial comparing fecal microbiota transplantation (FMT) to placebo in the treatment of mild to moderate Crohn’s disease

We plan to determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease. 

 

PI: Dr. Dina Kao

Study Coordinator: Rose Franz

Contact: butcher@ualberta.ca

STopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC): A Randomized, Open-label, Non-inferiority Trial

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Based on recent evidence, there is uncertainty regarding whether 5-ASA treatment is beneficial in maintaining remission (inactive disease) for people with Crohn’s. The study aims to determine whether 5-ASAs should be continued in people with CD who are in remission, by randomizing participants to either continue or discontinue their oral 5-ASA medication. The results of the study may have implications for the management of CD worldwide, and help to improve evidence based treatment guidelines and the approach to patient care.

PI: Dr. Brendan Halloran

Website: static-trial.com

Study Coordinator: Reed Sutton

Contact: reed.gastro@ualberta.ca


Studies on IBD and Pregnancy

VedoFAMUST: Vedolizumab and Ustekinumab in Family Planning

 

The University of Alberta Hospital IBD Unit is conducting an international mother-child pharmacovigilance study in women with IBD who become pregnant while on Ustekinumab (Stelara®) or Vedolizumab (Entyvio®).

This trial is for patients with CD, UC or indeterminate colitis who are pregnant, and continuing to take either Vedolizumab or Ustekinumab during the pregnancy. Participants must be willing to undergo trough blood sampling during pregnancy, at birth including a cord blood sample, and after pregnancy. Please contact the study coordinator for more information.

Study Coordinator: Meredith Porter, BScN, RN

Contact: (780) 492-8602

PI: Dr. Daniel Baumgart


 

To learn more about various aspects of research in IBD, please, go back to the IBD Research page

To go back to the IBD Unit main page click here