Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061912) titled 'Study on prediction of treatment response using fecal EDN in patients with inflammatory bowel disease' on June 15.

Study Type: Observational

Primary Sponsor: Institute - Shimane University Faculty of Medicine

Condition: Condition - Inflammatory bowel disease (ulcerative colitis, Crohn's disease) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to prospectively evaluate whether serum and fecal eosinophil-derived neurotoxin (EDN), as well as the EDN/fecal calprotectin ratio, reflect disease activity, endoscopic activity, inflammatory phenotypes, and treatment response to biologics or small-molecule therapies in patients with inflammatory bowel disease. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 10 Day Date of IRB - 2025 Year 06 Month 26 Day Anticipated trial start date - 2025 Year 06 Month 27 Day Last follow-up date - 2030 Year 02 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070810

Disclaimer: Curated by HT Syndication.