Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06453720
Eligibility Criteria:
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) ≥7 or ≥4 for isolated ileal CD and at least one large ulcer (≥5mm)
* Quiescent disease is defined as an SES-CD \<3.
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
* Antibiotics in the last 3 months for any indication
* Prebiotic, probiotic or postbiotic supplements in the last month
* 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 3 months.
* Prebiotic, probiotic or postbiotic supplements in the last month.
* Gastroenteritis or travel outside of Canada and the United States in the last month.
* Pregnant or breastfeeding.
* Previous bowel surgeries.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06453720
Study Brief:
Protocol Section:
NCT06453720