AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls
70 participantsStarted 2026-04-01
Plain-language summary
This pilot study will test a new imaging system that uses fluorescent dye and artificial intelligence (AI) during colonoscopy to measure how "leaky" the lining of the colon is in people with inflammatory bowel disease (IBD). The study will include 70 adults at 3 Canadian hospitals: 60 people with ulcerative colitis or Crohn's disease affecting the colon, and 10 people without IBD who are having colonoscopy for routine colorectal cancer screening or surveillance. During the colonoscopy, participants will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn. The main goal is to find out whether this method can be used safely during routine colonoscopy and whether it can produce usable measurements of mucosal permeability. The study will also examine whether these measurements are related to standard measures of inflammation seen during endoscopy, in biopsy samples, and in ex vivo Ussing chamber testing at the McMaster site. The control group will help define what normal fluorescence and permeability look like. This study is intended to provide early data on whether this approach could become a useful new way to assess barrier dysfunction in IBD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older
* Able to provide written informed consent
* Established ulcerative colitis or Crohn's disease involving the colon, or non-IBD control undergoing screening/surveillance colonoscopy
* Undergoing clinically indicated colonoscopy
* Ability to comply with study procedures
Exclusion Criteria:
* Allergy to fluorescein
* Colorectal cancer
* Advanced polyps or malignant lesions identified during colonoscopy
* Significant cardiopulmonary disease
* Renal failure
* Active infection or sepsis
* Severe IBD flare
* Use of medications that may affect gut permeability, including NSAIDs or antibiotics
* Inability to tolerate bowel preparation or safely complete the protocol
* Pregnancy or breastfeeding
* Inability or unwillingness to provide informed consent or comply with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Feasibility of Procedure
Timeframe: From enrollment to end of study = one patient visit
2
• Safety of the Imaging System
Timeframe: From enrollment to end of study = one patient visit