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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-21
SponsorCook Children's Health Care System

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Those with previous allergy to fluorescein

Pregnant and breastfeeding patients

Trial design

Treatments tested in this trial

  • Confocal Laser Endomicroscopy

Treatment groups

40 Participants
are divided into 1 treatment group