Inflammatory bowel disease (ulcerative colitis, Crohn'
Conditions
Interventions
None listed
Sponsors
Shimane University Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with ulcerative colitis or Crohn's disease; patients for whom clinical disease activity assessment, stool sampling, and endoscopic evaluation as needed are feasible during routine clinical practice; patients who provide written informed consent; and patients scheduled for initiation or switching of biologics or small-molecule therapy may be included.
Exclusion criteria
Exclusion criteria: Patients considered unsuitable for participation by the principal investigator or co-investigators; patients from whom adequate consent cannot be obtained; patients for whom sample collection or clinical data acquisition is difficult; and patients meeting any other exclusion criteria defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between baseline fecal EDN levels and the EDN/fecal calprotectin ratio and clinical disease activity indices in ulcerative colitis or Crohn's disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Associations of fecal EDN levels and the EDN/fecal calprotectin ratio with endoscopic activity; predictive performance of EDN-related markers before initiation of biologics or small-molecule therapy; longitudinal changes in EDN-related markers at approximately 16 and 52 weeks after treatment initiation and their association with clinical remission and relapse; additive value over existing biomarkers; and associations with mucosal cytokine profiles in a subset of patients. | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Mishima
Shimane University Faculty of Medicine Second Department of Internal Medicine
Outcome results
None listed