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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06604260
Eligibility Criteria:
Inclusion Criteria:
Group 1
\- Adults ≥18 years with confirmed diagnosis of Crohn's disease
AND one of the following:
* Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
* Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
* Active disease confiremed by endoscopy ( endoscopic SES-CD score \>3)
* Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2
* Adults ≥18 years with confirmed diagnosis of ulcerative colitis
AND one of the following:
* Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
* Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
* Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
Exclusion Criteria:
* Pregnancy
* Unable to provide informed consent
* IBD-related surgeries \< 5 years in medical history
* Colorectal carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06604260
Study Brief:
Protocol Section:
NCT06604260