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AI and dye join forces to spot leaky gut in IBD patients

NCT ID NCT07546955

Knowledge-focused Sponsor: Hamilton Health Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new imaging system that uses a fluorescent dye and artificial intelligence during colonoscopy to measure how leaky the gut lining is in people with inflammatory bowel disease (IBD). It includes 70 adults (60 with IBD and 10 without) at three Canadian hospitals. The main goal is to see if the procedure is safe and can produce usable measurements. This is an early-stage study to gather data, not a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

They will be patients of the Investigator and co-investigators. When the patient comes in for their usual clinical care and/or disease monitoring, the doctor will approach his or her own patients. If the patient is willing to learn more about the research project and provides consent to learn more, the doctor will introduce the patient to the study coordinator.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel disease (Crohn's disease; ulcerative colitis) Non-IBD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.