Ex-vivo Confocal Imaging and Proteomic Profiling for Pediatric IBD

This study is looking at children and young adults (ages 2-21) with Inflammatory Bowel Disease (IBD). Researchers want to see if a special imaging technique called Confocal Laser Endomicroscopy (CLE) and other tests on tissue samples can help predict how well someone with IBD will respond to treatment. You would undergo standard procedures like an EGD (Esophagogastroduodenoscopy) and/or Ileocolonoscopy (IC) with CLE, where small tissue samples (biopsies) are taken. The goal is to understand how certain proteins in these biopsies relate to your treatment outcomes and to develop a way to predict who will respond best to different therapies. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo an Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with Confocal Laser Endomicroscopy (CLE), which involves taking 3-4 mucosal biopsies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, number of FITC tagged antibodies, is measured at Baseline. Further follow-up is not specified.

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NCT07121920

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

Not Yet Recruiting
NAAges 2–21InterventionalDiagnostic
Cook Children's Health Care System
~40 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:Confocal Laser Endomicroscopy

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of FITC tagged antibodies
Measured over Baseline
IBD (Inflammatory Bowel Disease)
IBD
IBD - Inflammatory Bowel Disease
2 sites across 1 states
Texas2
  • Clifton Huang, MD · PRINCIPAL_INVESTIGATOR · Cook Children's Health Care System

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Eligibility criteria

Exclusion

Those with previous allergy to fluorescein
Pregnant and breastfeeding patients
  • Number of FITC tagged antibodiesBaseline

    Count of FITC tagged antibodies that maintain target specificity using fluorescence microplate reader. Used to establish baseline for fluorescent signal using FITC-tagged control antibody and control biopsy and IBD biopsy.