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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07456566
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD
* Impaired health-related quality of life
* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)
* Fecal calprotectin \> 250 microgram (ug/g)
* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60
Exclusion Criteria:
* Unable to speak and read English
* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components
* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses
* Are planned for imminent surgery
* Have short bowel syndrome
* Uncontrolled medical or psychiatric disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07456566
Study Brief:
Protocol Section:
NCT07456566