Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059411) titled 'Balloon-assisted Enteroscopy for Assessment and Correlation with biomarkers in small bowel Crohn's disease' on Nov. 1.

Study Type: Observational

Primary Sponsor: Institute - Science Tokyo

Condition: Condition - Crohn's disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the association between small bowel lesion activity assessed by balloon assisted enteroscopy and biomarkers including serum LRG as well as stool and urine biomarkers and to validate cut off values that enable estimation of the presence and activity of small bowel lesions. Basic objectives2 - Others

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals diagnosed with ileal or ileocolonic type Crohn's disease. Individuals scheduled to undergo balloon assisted enteroscopy for lesion assessment. Individuals who provide informed consent to participate and for whom biomarker measurements can be obtained. Key exclusion criteria - Individuals diagnosed with colonic type Crohn's disease. Individuals with evident active perianal disease or perianal abscess. Individuals with conditions contraindicating balloon assisted enteroscopy. Individuals with malignancy; active infections (including the common cold); chronic inflammatory diseases (e.g., rheumatoid arthritis); or other serious comorbidities (e.g., hepatic or renal failure). Individuals who have taken NSAIDs within the past 1 week. Individuals who have taken stimulant laxatives within the past 1 week. Individuals within 3 months of initiating biologic or JAK inhibitor therapy. Pregnant or lactating individuals. Any other individuals deemed unsuitable by the principal investigators. Target Size - 243

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067946

Disclaimer: Curated by HT Syndication.