Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD
Not applicable · Testing Confocal Laser Endomicroscopy · 2 sites · Cook Children's Health Care System
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Confocal Laser Endomicroscopy (a device) as a way to diagnose or measure disease. Condition(s) listed: IBD (Inflammatory Bowel Disease), IBD and IBD - Inflammatory Bowel Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 2 to 21
- Any sex
Some of the main requirements, copied from the record:
- \- 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…
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-09-01 (planned).
- Main results expected around 2027-07-01 (estimate from the record).
- 2 study sites listed in United States.
Main thing being measured
- Number of FITC tagged antibodies (Baseline)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | IBD (Inflammatory Bowel Disease); IBD; IBD - Inflammatory Bowel Disease |
| Lead sponsor | Cook Children's Health Care System |
| Enrollment | 40 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2027-07-01 |
| First posted | 2025-08-14 |
| Last updated | 2025-08-14 |
| Official title | A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07121920 |
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/…
Full eligibility criteria (from the record)
Inclusion Criteria: \- 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 Exclusion Criteria: * Those with previous allergy to fluorescein * Pregnant and breastfeeding patients
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas at Arlington | Arlington, Texas | United States | |
| Cook Children's Health Care System | Fort Worth, Texas | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.