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

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2028

Conditions
IBD (Inflammatory Bowel Disease)IBDIBD - Inflammatory Bowel Disease
Interventions
DEVICE

Confocal Laser Endomicroscopy

"Patients will undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) EGD with CLE as per standard of care. Each participant will have 3-4 mucosal biopsies taken from the terminal ileum, rectosigmoid and cecum, ideally from the most affected areas of accessible segment.~Ex vivo staining of biopsied tissue will be expanded to include FITC-labeled antibodies to cytokines IL12 and IL12/IL23 and to cytokine receptors IL12R and IL23R and possibly other cytokines, receptors and adhesion molecules. All biopsies tested for membrane bound antibodies will be done using CLE technology with artificial intelligence (AI). The cellular landscape will be characterized by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.~We will develop algorithm using AI to predict responders versus non-responders and to further subclassify IBD patients using phenotype data."

Trial Locations (2)

76010

University of Texas at Arlington, Arlington

76104

Cook Children's Health Care System, Fort Worth

All Listed Sponsors
lead

Cook Children's Health Care System

OTHER