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?

PALI-2108 is a new oral medication designed to treat ulcerative colitis (UC) by targeting the intestines. It works as a phosphodiesterase-4 (PDE4) inhibitor prodrug, meaning it becomes active only after being processed by bacteria in the colon. This targeted approach reduces the risk of side effects that can occur with other medications that affect the entire body.

Recent studies have shown that patients with active UC, especially those with moderate to severe symptoms, have higher levels of PDE4 and related biomarkers. These biomarkers are linked to the severity of their disease, suggesting that inhibiting PDE4 could help manage UC effectively.

The goal of this Phase 1 study is to evaluate the safety, tolerability, and how the body processes (pharmacokinetics) and responds to (pharmacodynamics) PALI-2108 in healthy volunteers. Although there are already PDE4 inhibitors on the market, PALI-2108 is a completely new compound that has not been tested in humans before.


Who can Participate?

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

• You are aged at least 18 years but not older than 70 years
• Your body mass index (BMI) is within 18.5 kg/m2 to 35.0 kg/m2, inclusively
• You have received a diagnosis of moderate to severe UC, established at least 6 months prior to screening
• You are located in Montreal, QC or are willing to commute to our location

Your Role in this Study

The study will involve two parts: first, participants will receive single doses of the drug, and then, in the second part, they will take it twice a day for seven days.

The twice-daily dosing schedule is designed to maximize drug exposure in the colon. The investigators will also investigate how food affects the drug's absorption.

Additionally, a small group of stable UC patients will be included in the study. These patients will also take PALI-2108 for seven days, allowing us to compare the safety and drug processing between healthy individuals and those with UC. The investigators will monitor important health markers and conduct tests on colon tissue to see how well the drug works and if it causes any changes in the tissue.

Including UC patients early in this research is important for understanding how the drug performs in real-world conditions. This data will help refine our approach to identify which patients might benefit most from PALI-2108 in future studies.

Overall, this study aims to gather crucial information about PALI-2108's safety and effectiveness, paving the way for new treatment options for patients with ulcerative colitis.


This study has been approved by the Advarra Research Ethics Board (REB #Pro00082379).


Primary Contact
Bich-Chau Le
participants@altasciences.com

Principal Investigator
Dr. Gaetano Morelli
Altasciences Company Inc.

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?

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?

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 purpose of this study is to understand the genetic factors that might be contributing to inflammatory Bowel Disease in individuals of Black or Hispanic/Latinx ancestries. We hope our findings will help in personalizing treatments for IBD.

Your Role in this Study

Participants will be asked to:

• donate one tablespoon of blood and/or saliva sample
• complete a questionnaire about their IBD history
• provide access to their medical records

Who can Participate?

Participants must:

• Self-identify as African American or Black or;
• Self-identify as Hipanic/Latinx;
• Have been diagnosed with Crohn’s Disease or Ulcerative Colitis;
• Be willing to donate blood and/or saliva sample;
• Be willing to give the study access to your medical records.

All ages are welcome, and participants must have confirmed (via medical records access) IBD. They will also receive compensation for their time after completing all study procedures. The study is located at the Mount Sinai Hospital, Toronto, ON.

This study has been approved by the Mount Sinai Hospital Research Ethics Board (REB# 02-0234-E).

Primary Contact
ibd.research@sinaihealth.ca

Principal Investigator
Mark Silverberg
Mount Sinai Hospital