Clinical Trial

Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD

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Summary
This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed. The key questions under investigation are: Aim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy). Aim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD. Aim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.
Trial Details
NCT Number NCT07121920
Lead Sponsor Cook Children's Health Care System
Conditions IBD (Inflammatory Bowel Disease), IBD, IBD - Inflammatory Bowel Disease
Enrollment 40 participants
Start Date 2025-09-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-14