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. Richard N Fedorak

Contact: Dr. Ellina Lytvyak     lytvyak@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. Richard N Fedorak

Contact: Reed Sutton     reed.gastro@ualberta.ca

 

IBD eClinician-integrated Clinical Care Pathways as an Innovative Model of Care to Improve Flare Management and Corticosteroids Administration in Ambulatory Setting: A Randomized Controlled Trial

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. Richard N Fedorak


Studies on IBD

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


Studies on Ulcerative colitis

PATIENT-UC: Patient Centered Algorithms to opTimize the Inpatient Experience aNd Treatment of Ulcerative Colitis

Patients with UC may require hospitalization whena disease flare is severe. Hospitalized patients are at increased risk for complications such as infections, blood clots, and surgery. Even though there are guidelines on how to best treat patients with UC in hospital, there is a lot of variety in how UC patients are cared for.

Admission to hospital can also have a significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease.  Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic disease. We proposed the development of a patient-centered initiative aimed at improving important outcomes through an educational tool for patients admitted to hospital with UC. 

 

PI: Dr. Adam Weizman          Site PI: Dr. Vivian Huang

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), Ogi (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

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. Richard Fedorak

Website: static-trial.com

Study Coordinator: Reed Sutton

Contact: reed.gastro@ualberta.ca


Studies on IBD and Pregnancy

The studies investigating fertility, conception and pregnancy in IBD patients and their families can be found here.


 

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