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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02612103
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Written informed consent
* and one of:
* for Crohn's disease - active disease: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index \> 4.
* for Crohn's disease - disease in remission: Verified CD diagnosis according to clinical, endoscopic and histological standard criteria and Harvey Bradshaw index ≤ 4.
* Ulcerative colitis - active disease: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI \> 3.
* Ulcerative colitis - in remission: Verified UC diagnosis according to clinical, endoscopic and histological standard criteria and SCCAI ≤ 3.
* Irritable bowel syndrome: Verified IBS according to standard criteria.
* Healthy control: No known chronic diseases which needs continuously medication.
Exclusion Criteria:
* Common to all participants:
* Patient with ostomy or pouch.
* The patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year
* The patient is in a poor general condition.
* The patient is pregnant at the time of inclusion or has planned pregnancy during the period of study.
* The patient cannot understand the information material.
* Healthy control:
* The patient has a chronic disease.
* IBS symptoms according to standard criteria.
* The patient has had any type of illness within the last 14 days (for example diarrhea, a cold etc.).
* The patient has any type of on-going medication or new medication within the last 14 days (except contraceptive pills and vitamins).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02612103
Study Brief:
Protocol Section:
NCT02612103