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?

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.

What is this Study About?

The risk for clinical depression is 3 times higher in patients withinflammatory bowel disease (IBD). We think IBD may be linked to brain inflammation, increasing the risk for clinical depression. This link has not been studied before. This study measures whether brain inflammation occurs in people with IBD and which treatments of IBD are best in reducing brain inflammation.

Who can Participate?

Participants with a diagnosis of Crohn's Disease or Ulcerative Colitis, aged 18-65 years old, no history of neurological illness, not currently taking any recreational drugs, not pregnant or breastfeeding.

This study has been approved by the Centre for Addiction and Mental Health Research Ethics Board (REB #102/2016)

Primary Contact
Joeffre Braga
ibd.study@camh.ca

Principal Investigator
Dr. Jeffrey Meyer
Centre for Addiction and Mental Health

What is this Study About?

Inflammatory bowel disease (IBD) is a lifelong chronic inflammatory condition that requires ongoing interactions with the healthcare system. However, not everyone may feel safe accessing and receiving IBD-related care or communicating openly with their provider. One such marginalized group of individuals who may not feel comfortable are those who identify as transgender or gender diverse.

The purpose of this multidisciplinary, patient-oriented, pilot qualitative study is to explore care experiences and expectations in transgender and gender diverse individuals who live with IBD.

Who can Participate?

Individuals who are Canadian adults 18 years or older; are diagnosed with Crohn's disease or ulcerative colitis; and who self-identify as transgender or gender diverse are invited to participate.

Your Role in this Study

Individuals will have an opportunity to be interviewed virtually (via Zoom) either individually or in a group setting.

The goal of this project is to allow individuals a supportive place to share their experiences regarding accessing and receiving IBD-related care and to understand what strategies would encourage a comfortable and safe IBD-related healthcare space for individuals who are transgender or gender diverse.

This study has been approved by the University of Saskatchewan's Research Ethics Board (REB #4455).

Primary Contact
Natasha Tooke
natasha.tooke@usask.ca

Principal Investigator
Noelle Rohatinsky
University of Saskatchewan

What is this Study About?

Fibrosis (thickening and scarring) within the intestinal tract is common in patients with Crohn’s Disease. There are currently no approved therapies for treating fibrosis in the intestinal tract and therefore there is an urgent need for safe and effective antifibrotic therapies in fibrostenotic Crohn’s Disease. This oral therapy is hoping to be able to change that and help relieve stricturing Crohn’s Disease without having patients undergo surgery.

Who can Participate?

Patients age 18 and older with stricturing Crohn’s Disease. Patients must be living in Toronto, ON and able to travel.

Your Role in this Study

This study lasts for about 16 weeks and consist of a screening period, treatment period and safety follow-up.

Screening period (can last up to 35 days): Participants will come on site to go over their medical history, current and past medications, do an ECG (electrocardiogram), and colonoscopy. Patients will also go off site to Mount Sinai Hospital to complete an MRI for the intestines and an echocardiogram

Treatment period (last 12 weeks): Participants will come on site every 2-4 weeks for a doctor and nurse to do an assessment on their health and do an ECG. Participants will also be given study medication. At the final 12 week visit, participants will undergo a colonoscopy and ECG on site and an MRI and echocardiogram at Mount Sinai Hospital again.

This study has been approved by the Advarra Research Ethics Board (REB #SSU00224057).

Primary Contact
Mindy Xu
mxu@tidhi.ca

Principal Investigator
Dr. Mark Silverberg
TIDHI Innovation Inc.

What is this study about?

We want to test if fasting for certain hours daily can help with weight loss and improve gut inflammation. We are asking patients with Crohn’s disease who struggle with weight to participate in this 12-week study.

Your Role in this Study

If you join this study, you could be put into two groups. The first group does not fast and eats as usual. The second group is the group that will fast.

The fasting group fasts for a certain number of hours 6 days a week. They will eat their regular diet during their eating window. They will also meet with a registered dietitian (RD) online. The RD will teach the patient how to fast and help answer questions. The research assistant will call patients every two weeks to discuss changes in medications, disease symptoms and how well the patient is doing with the fasting.

The other group will be asked to eat their regular diet over the 12-week study. At the end of the study, they will get to meet with the RD and do the fast as well. The research assistant will call patients every two weeks to discuss medication changes and disease symptoms.

Both groups will complete surveys at the start and end of the study. These surveys will ask about your quality of life and physical activity levels.

Who can Participate?

We are recruiting patients who:

• are located in Calgary, AB or Kelowna, BC;
• are 18-70 years of age;
• struggle with their weight;
• and are affected by Crohn's disease.

This study has been approved by the University of Calgary's Conjoint Health Research Ethics Board (REB21-1539_REN1).

Primary Contact
Munazza Yousuf
munazza.yousuf1@ucalgary.ca

Principal Investigator
Maitreyi Raman
University of Calgary