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:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT04827368
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed as having Crohn's Disease or Ulcerative Colitis
* Aged 18-70 years.
* Understands the language and signs an informed consent form.
* Any disease location, except isolated upper GI Crohn's disease only
* Any CD or UC disease activity.
* Outpatients and inpatients
* Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.
Exclusion Criteria:
* Status post colectomy
* Status post diverting loop ileostomy or end ileostomy or colostomy
* On antibiotics in the past 3 months or currently
* Women (pregnant or breast feeding)
* Subjects with concurrent chronic liver, renal, lung or metabolic disorders
* Active malignancy
* Bowel preparation at day of sample procurement
* Isolated upper GI Crohn's disease only
* Active disease on colonoscopy, but normal fecal calprotectin at inclusion
* C diff. positive at time of inclusion (test to be obtained in routine clinical care).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04827368
Study Brief:
Protocol Section:
NCT04827368