Predicting treatment outcomes for Crohn's disease using gut microbiome analysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify specific microbiome signatures that can predict therapeutic responses in adult patients with Crohn's disease living in British Columbia, Canada. Researchers will analyze microbiome profiles from fecal samples, intestinal washings, and biopsies taken during routine colonoscopy to determine differences between active and quiescent disease states. The study will involve longitudinal follow-up over 12 months to monitor clinical outcomes and assess the correlation between microbiome signatures and treatment responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• GI Research Institute
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Fanny LeMarié, PhD
• Email: flemarie@ibdcentrebc.ca
• Phone: 6044414992

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.