Clinical Trials Directory

Trials / Completed

CompletedNCT02434705

Food Antigen in Eosinophilic Esophagitis

Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it starts an chronic allergy-based inflammation. This will be analyzed with the esophageal biopsies and the mucosal impedance probe.

Detailed description

One of the putative mechanisms of eosinophilic esophagitis is exposure of food antigens to antigen recognition cells in the esophageal mucosa that initiates a chronic allergy-based inflammatory response . It is believed that this exposure is facilitated through dilation of the intercellular spaces (DIS) between esophageal epithelial cells (termed spongiosis). This is substantiated by several studies which have demonstrated that: first, DIS is commonly found in biopsies from patients with active EoE and reverses with steroid therapy; second, DIS correlates to physiologic demonstration of increased esophageal epithelial permeability as shown through transepithelial small molecule flux in mucosal biopsies appraised in Ussing chambers and increased conductivity of electric current as measured in a mucosal impedance probe (Katzka, et al., in press, Clin Gastroenterol Hepatol). Although these mechanisms make intuitive sense, no one has shown the presence of food antigen in esophageal mucosa after ingestion and the correlation of this presence to dilation of intercellular spaces.

Conditions

Interventions

TypeNameDescription
OTHERAntigen (wheat base soy sauce) sprayPatients having a clinically indicated endoscopy for Eosinphilic Esophagitis will have two biopsies from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and Two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction.

Timeline

Start date
2015-04-01
Primary completion
2023-12-08
Completion
2023-12-08
First posted
2015-05-05
Last updated
2023-12-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02434705. Inclusion in this directory is not an endorsement.