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Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration
Sponsor: Cook Children's Health Care System
Summary
The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low/low levels of Immunoglobulin E (IgE) serological tests.
Official title: A Multicenter Ambispective Evaluation of Atypical Food Allergies In-vivo Utilizing Confocal Laser Endomicroscopy in Pediatric and Adult Patients
Key Details
Gender
All
Age Range
2 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-03
Completion Date
2034-09
Last Updated
2025-02-24
Healthy Volunteers
No
Conditions
Interventions
Confocal Laser Endomicroscopy
1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously. 2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each 3. The first potential allergen will be sprayed via catheter onto the mucosa. 4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.