Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-99
SponsorCook Children's Health Care System
About this trial
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.
Eligibility criteria
Qualifiers
Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.
A negative or very low/low levels of Ig-E food allergy panel or negative skin prick test
Negative celiac disease work up
Disqualifiers
If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.
Pregnant or nursing at the time of CLE.
Known allergy to fluorescein.
Impaired renal function tests.
Trial design
Treatments tested in this trial
- Confocal Laser Endomicroscopy
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Cook Children's Health Care System
Lead sponsor
University of Nebraska Medical Center and Children's Hospital & Medical Center
Collaborator
Stanford University
Collaborator
Metrodora Institute
Collaborator
Meliora Bio ApS
Collaborator
Source ClinicalTrials.gov