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Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv2
  2. Study First Submitted
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.
Trial Details
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
(from sponsor)		 Irritable Bowel Syndrome, Food Allergy
Related terms Food Hypersensitivity, Irritable Bowel Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov