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This study examines whether gut microbiome analysis can be used to predict treatment outcomes in people with inflammatory bowel disease (IBD), through colonoscopy. It is enrolling patients aged 19-80 with Crohn's disease that can be assessed by colonoscopy, along with non-IBD controls undergoing colonoscopy for colorectal screening. It is being run as a study with no assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.