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

Starting soon · Not applicable

Conditions studied: IBD (Inflammatory Bowel Disease), IBD, IBD - Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID: NCT07121920
Run by: Cook Children's Health Care System
People needed: 40
Starts: 2025-09-01
Expected to finish: 2028-07-01
Last updated by the study team: 2025-08-14

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must fall into one of the below categories: (i) with suspected and/or established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls

You may not qualify if…

Those with previous allergy to fluorescein
Pregnant and breastfeeding patients

Where it is running

University of Texas at Arlington — Arlington, Texas, United States
Cook Children's Health Care System — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.