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

NCT07121920 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

IBD - Inflammatory Bowel Disease; IBD

Keywords

Ex-vivo; Inflammatory bowel disease; IBD; CLE; Confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Number of FITC tagged antibodies

  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.

  Baseline

Study Arms (1)

Intervention

EXPERIMENTAL

Pediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management

Device: Confocal Laser Endomicroscopy

Interventions

Confocal Laser Endomicroscopy DEVICE

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.

Intervention

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Cook Children's Health Care System: lead

Study Sites (2)

University of Texas at Arlington

Arlington, Texas, 76010, United States

Location

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Clifton Huang, MD

  Cook Children's Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumith Roy, MBBS, MPH

CONTACT

682-885-1790; Sumith.Roy@cookchildrens.org

Chief Research Officer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)