Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

September 30, 2033

Study Completion Date

September 30, 2034

Conditions
Irritable Bowel SyndromeFood Allergy
Interventions
DEVICE

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."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Nebraska Medical Center and Children's Hospital & Medical Center

UNKNOWN

collaborator

Stanford University

OTHER

collaborator

Metrodora Institute

UNKNOWN

collaborator

Meliora Bio ApS

UNKNOWN

lead

Cook Children's Health Care System

OTHER