Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

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.

NCT Number	NCT06792838
Lead Sponsor	Cook Children's Health Care System Collaborators: University of Nebraska Medical Center and Children's Hospital & Medical Center, Stanford University, Metrodora Institute, Meliora Bio ApS
Conditions	Irritable Bowel Syndrome, Food Allergy
Enrollment	200 participants
Start Date	2025-03
Primary Completion	2033-09 (estimated)
Study Completion	2034-09 (estimated)
Updated on ClinicalTrials.gov	2025-02-24