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Gut microbiome may hold key to personalized Crohn's therapy

NCT ID NCT06453720

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether the unique mix of bacteria and fungi in the gut can predict how well Crohn's disease patients will respond to treatment. Researchers will collect stool, blood, and tissue samples from 100 adults during routine colonoscopies and track their health for a year. The goal is to find microbial signatures that could one day help doctors choose the most effective therapy for each patient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors predict which treatments will work best for individual Crohn's disease patients based on their gut microbiome.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. The findings may not lead to immediate clinical changes.

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 100 people

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

Started

Aug 2024

Expected to finish

Apr 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

The investigators aim to have 75 CD patients complete phase 1 and 2, and 25 non-IBD controls to complete phase 1 only. Patient grouping for recruitment is as follows: * Group 1: 25 CD in endoscopic remission (SES-CD score \<3). * Group 2: 25 CD with moderate to severe endoscopically active disease (SES-CD ≥ 7 or ≥ 4 for isolated ileal CD). * Group 3: 25 CD with mildly endoscopically active disease (SES-CD of 3-6, or 3 with isolated ileal CD). * Group 4: 25 age, sex-matched non-IBD controls.

Ages

19 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: CD patients: * Adult patients ≥19 years old and ≤ 80 years old. * CD with distal small bowel and/or colonic involvement that is endoscopically assessable with colonoscopy. * Undergoing colonoscopy as part of routine clinical care. * Active or quiescent disease. * Active disease will be defined as a simple endoscopic score for CD (SES-CD). * Quiescent disease is defined as an SES-CD \<3. * Mild active disease will be defined as a SES-CD of 3-6, or 3 with isolated ileal CD. * Moderate/severe active disease will be defined as a simple endoscopic score for CD (SES-CD) ≥ 7 or ≥ 4 for isolated ileal CD. Non-IBD controls: * Adult patients ≥ 19 years old and ≤ 80 years old. * Undergoing colonoscopy as part of colorectal screening. Exclusion Criteria: CD patients: * Active perianal CD - defined as collection on MRI or clinically active fistula (i.e., draining fistula). * Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or isolated upper GI CD. * Colectomy or Proctocolectomy. * Pouch, J-Pouch or Reversed pouch surgery. * Short Bowel Syndrome (SBS) diagnosis. * Antibiotics in the last 2 months for any indication. * Gastroenteritis or travel outside of Canada and the United States in the last month. * Colorectal cancer, high-grade dysplasia or a polyp ≥2cm diagnosed at baseline endoscopy. * Pregnant or breastfeeding. * Bowel resection within the preceding 4 months. * Primary sclerosing cholangitis. Non-IBD controls: * Found to have inflammation (deemed by endoscopist) at colonoscopy. * History of IBD in 1st degree relative. * Antibiotics in the last 2 months. * Gastroenteritis or travel outside of Canada and the United States in the last month. * Pregnant or breastfeeding. * Previous bowel surgeries.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • GI Research Institute

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

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