Research

What is this Study About?

The IMAGINE Network is currently recruiting healthy individuals along with persons with inMammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Our goal is to recruit 8,000 subjects and will study how three important variables (genes, diet and mental health) impact the gut microbiome and, in turn, how together they impact the disease course.

Who can Participate?

Adults or children with IBD or IBS, or healthy subjects

This study has been approved by the Hamilton Integrated Research Ethics Board (REB #3000).

Primary Contact
Aida Fernandes
fernaa19@mcmaster.ca

Principal Investigator
Paul Moayyedi
McMaster University

What is this Study About?

The aim of this initiative is to gather culturally relevant information on the care and management of inflammatory bowel disease (IBD). This information will be used to guide the development of educational materials presented in Arabic, Farsi, Filipino/Tagalog, Hindi, Mandarin, Punjabi, and Spanish. These materials will be made widely available to Canadians with the hope of making IBD resources more accessible.

Who can Participate?

You are invited to take part in this research study if:

• You have inflammatory bowel disease (IBD), Crohn’s Disease (CD), or Ulcerative Colitis (UC)
• You are not optimally fluent in English
• You are a speaker of one of the following languages: Arabic, Farsi, Filipino/Tagalog, Hindi, Mandarin, Punjabi, and/or Spanish
• You immigrated to Canada from another country (you are a new Canadian)

Your Role in this Study

Individuals who are living with IBD, were born outside of Canada, and are primarily fluent in Arabic, Farsi, Filipino/Tagalog, Hindi, Mandarin, Punjabi, and/or Spanish will be invited to participate in a 2.5 hour-long virtual focus group with 4-5 other individuals and 1 facilitator. During the focus group, participants will be asked to speak about their experiences around being diagnosed with IBD, making decisions around medications for their IBD, and about their diet and mental health as it relates to IBD. Conversations during the focus group will be audio recorded so they may later be used to develop educational materials in each language. No personally identifying information will be collected. Participants may refuse to answer any questions and if need be, withdraw from the group at any time. A token of appreciation will be provided to those who decide to participate in this educational initiative.

This study has been approved by the Mount Sinai Hospital's Research Ethics Board (REB #24-0073-E).

Primary Contact
Eva Stefanova
eva.stefanova@sinaihealth.ca

Principal Investigator
Laura Tagownik
Mount Sinai Hospital

What is this Study About?

There are multiple treatments in Crohn's disease (CD). Most of the studies approving these drugs include a placebo arm with very few studies to date (SEQUENCE, SEAVUE, VIVID-1) including direct comparisons between drugs. One of the key research questions set out by the UK James Lind Alliance research priority setting partnership scheme is "what is the best treatment or sequence of treatments in Inflammatory Bowel Disease?"

To answer the question of which is the best treatment and which is the best sequence of treatment we have undertaken a network meta-analyses. The evidence (both the direct comparisons, real world data sets and the network-meta-analyses) show that most drugs are very similar in efficacy and it is still hard to decide which is the best treatment in CD. To best answer this question we feel that a multi-arm, multi-intervention strategy (MAMS) trial is needed to compare all present treatments in CD.

Moreover, small cohort studies are suggesting that combination of advanced therapies may be very effective. We plan a multi-arm multi-intervention trial to investigate and compare the efficacy of single and combination advanced therapies in CD.

Who can Participate?

• Adults (over 18 years of age) who have IBD
• Medical professionals
• Nursing professionals
• Pharmacists
• Healthcare service managers and commissioners

Your Role in this Study

We need your help to design this study. Everyones opinion and experiences will be helpful in helping the research team to design this clinical trial. We want to hear from all kinds of people with experiences of CD - including people living with the condition or caring for people who have it.

We are now investigating the opinions, perceptions and expectations of the appropriate population(s), intervention(s) and comparator(s) which should be included in a platform MAMS trial for assessing safety, efficacy and cost effectiveness of advanced therapies in CD. We  want your opinion if and when should combination advanced therapies be used in a research study in CD. The steering committee of this study have undertaken an initial discussion on the trial design for this study.

This study has been approved by the University of Nottingham's Research Ethics Board (REB #FMHS 54-1224).

Primary Contact
Shellie Radford

What is this Study About?

Participants are invited to participate in a research study conducted by a collaborative group of international researchers and the Inflammatory Bowel Disease service at The Queen Elizabeth Hospital (South Australia, Australia). Before deciding whether to participate, it is important for you to understand why this research is being conducted and what your involvement will entail. Please take the time to read the following information carefully.

The purpose of this study is to find out whether people with ulcerative colitis consume dietary protein supplements. We also want to understand your views on consuming protein supplements. You do not have to be consuming protein supplements to participate in this study.

Who can Participate?

Adults (≥18 years old) who are able to read and interpret English and have a diagnosis of UC self-confirmed via colonoscopy and biopsy will be invited to participate in this study.

Your Role in this Study

Participation in this study will involve completing an anonymous survey online. This survey is expected to take 10-20 minutes to complete. The survey will ask some questions about you (e.g., age group, geographical location) but will not collect any identifiable information from you.The second part of the survey will involve rating statements about protein supplements on a scale to find out your views on whether protein supplements are beneficial. Lastly, you will be asked about any consumption of dietary protein supplements in the last six months. If you have consumed protein supplements, some additional questions will follow for further details on your protein supplement use.

Access the survey here: https://survey.redcap.sahealth.sa.gov.au/surveys/?s=7KPLLWRDR7XWJ3H3

This study has been approved by the Central Adelaide Local Health Network Research's Human Research Ethics Committee (REB #19770).

Primary Contact
Rachel Davis
Rachel.Davis2@sa.gov.au

Principal Investigator
Rachel Davis
The Queen Elizabeth Hospital (Australia)
 

What is this Study About?

The purpose of this PhD (doctoral of philosophy) thesis/dissertation study is to explore the lived experiences and perspectives of people with IBD in SK regarding complementary health approaches that involve dietary practices and access to nutrition care services in Saskatchewan to improve understanding of their perceived effect on disease-related symptoms and food-related quality of life. Through one-on-one semi-structured interviews of people with IBD, the objectives of this study are to:
 

• Explore experiences of people with IBD with regards to food intake, dietary supplement, and other dietary practices;
• Explore experiences regarding nutrition care, the enablers and barriers to nutrition service accessibility from dietitians, other health care professionals and nutrition-related supports and resources; and
• Investigate perceived effect of dietary practices (including accessing and receiving nutrition care services) on IBD-related symptom management and food-related quality of life (FRQOL)

Significance: To our knowledge, this study is the first in SK to investigate complementary health approaches in persons with IBD while also aligning with the philosophy and practice of patient-centred care of the Saskatchewan Heath Authority (SHA).  An important aspect of patient-centred care in SK is recognizing the importance of “lived experiences” and providing a platform for patient voices and perspectives to be heard. This study provides that platform in addition to providing an important role engaging people as part of the research process to help understand dietary practices and nutrition care services for IBD in SK.

A greater emphasis on “lived experiences” and a patient centred approach may help develop and prioritize improvement strategies that may include patient resources, clinical practice guidelines or models of nutrition care services. These strategies may in turn help empower people to make informed decisions and improve shared decision-making amongst healthcare professionals when considering complementary health approaches that involve MC and dietary practices as part of IBD management in SK. The result may help with a more congruent integration of complementary health approaches with corresponding care to buffer healthcare costs, manage unique health challenges, and enhance support for people with IBD.

Ultimately, the findings from this research may improve the lives of people with IBD by improving disease-related symptoms, overall QOL, and psychosocial well-being with enhanced support in a more seamless SK healthcare system.A broader dissemination of this knowledge to policy makers and stakeholders within the SHA may also encourage meaningful change for dietitian care services as part of a patient-centred approach to multidisciplinary based care.

Who can Participate?

Adults 18 years of age or older diagnosed with IBD who currently reside in Saskatchewan.

This study has been approved by the University of Saskatchewan's Behavioural Research Ethics Board (REB #5116).

Primary Contact
Jennifer Chami
jennifer.chami@usask.ca

Principal Investigator
Jessica Lieffers
University of Saskatchewan

What is this Study About?

Tulisokibart is an anti-TL1A monoclonal antibody. TL1A is shown to be upregulated in mucosa (colon) and serum (blood) of patients with IBD. Through this process, it has the potential to improve inflammatory and fibrotic diseases related to the immune system.

Who can Participate?

• Individuals 18-75 years of age (inclusive)
• Diagnosed with Crohn’s Disease or Ulcerative Colitis
• Located in Toronto, ON or is willing to commute to our location for treatment

Your Role in this Study

A phase 2 study was completed with Tulisokibart in patients with moderate to severe Crohn’s Disease and Ulcerative Colitis. Majority of the patients included in this study have failed infliximab (Remicade, Humira, etc) and/or vedolizumab (Entyvio). The phase 2 results were positive and demonstrated that patients treated with Tulisokibart were more likely to achieve clinical remission (0-2 more bowel movements than normal and no rectal bleeding), endoscopic improvement (no inflammation or mild inflammation), and clinical response (30% reduction in stool frequency and rectal bleeding) after 12 weeks of treatment compared to patients on placebo. As a result of these positive results, Health Canada, FDA, and EMA approved this phase 3 study.

This Phase 3 Study is placebo controlled with 25% chance of entering the placebo treatment group. However, if at the end of the first 12 weeks you are not responding to the medication (symptoms and inflammation in your colon does not improve), participants will be able to transition to a new group and receive Tulisokibart (no chance of placebo).

This study has been approved by the Advarra Research Ethics Board (REB #Pro00074917).

Primary Contact
Mindy Xu
mxu@tidhi.ca

Principal Investigator
Dr. Mark Silverberg
TIDHI Innovation Inc.

What is this Study About?

Obefazimod is an oral therapy that induces and increases miR-124 release which aids in reduction of inflammation through reducing several cytokines.

A phase 2 study was completed with Obefazimod in patients with moderate to severe Ulcerative Colitis.

The phase 2 results were positive and demonstrated that patients treated with Obefazimod were more likely to achieve clinical remission, endoscopic improvement, and clinical response after 8 and 48 weeks of treatment compared to patients on placebo. As a result of these positive results, a phase 3 of the study will be conducted to assess further effectiveness in a larger population.

Who can Participate?

• Individuals 16 years of age or older weighing at least 40kg if adolescent
• Diagnosed with Ulcerative Colitis
• Has never been exposed to Rinvoq, Xeljanz, or other JAK Inhibitors
• Located in Toronto, ON or is willing to commute to our location for treatment

Your Role in this Study

This Phase 3 Study is placebo controlled with 25% chance of entering the placebo treatment group. However, if at the end of the first 8 weeks you are not responding to the medication (symptoms and inflammation in your colon does not improve), participants will be able to transition to a new group and receive Obefazimod (no chance of placebo).

This study has been approved by the WCG Research Ethics Board (REB #20223812).

Primary Contact
Mindy Xu
mxu@tidhi.ca

Principal Investigator
Dr. Mark Silverberg
TIDHI Innovation Inc.
 

What is this Study about?

The purpose of the study is to evaluate the use of intestinal ultrasound in assessing bowel healing in Crohn’s Disease patients on Entyvio. Participants will be randomly assigned in a 1:1 ratio of having ultrasound done at baseline, week 14, 22, 30, 38, and 48, compared to just at baseline and week 48.

Who can Participate?

Patients ages 18-80  (inclusive) with moderate to severe Crohn’s disease that has failed less than 2 biologics/small molecules.

Your Role in this Study

Participants will receive Entyvio on the induction regime of 300mg IV at weeks 0, 2, 6, 10, followed by every 8 weeks afterwards.

This study will last approximately 100 weeks and consist of the following:

• Screening Period: up to 4 weeks
• Treatment optimization phase: 48 weeks
• Post-treatment optimization follow-up phase: 48 weeks

Please note: colonoscopies, stool/blood samples, intestinal ultrasounds, and etc are also done as part of the study.

This study has been approved by the Advarra Research Ethics Board (REB #Pro00075825).

Primary Contact
Mindy Xu
mxu@tidhi.ca

Principal Investigator
Dr. Mark Silverberg
TIDHI Innovation Inc.