Overview

This trial is active, not recruiting.

Condition eosinophilic esophagitis
Treatment antigen (wheat base soy sauce) spray
Phase phase 0
Sponsor Mayo Clinic
Start date April 2015
End date April 2017
Trial size 20 participants
Trial identifier NCT02434705, 15-000883

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Ten patients with active and ten with inactive eosinophilic esophagitis (defined by consensus guidelines) undergoing clinically indicated endoscopy and esophageal biopsies will participate in this study. During the endoscopy two biopsies will be taken from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce (antigen spray) 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.
antigen (wheat base soy sauce) spray Wheat based soy sauce
Patients 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.

Primary Outcomes

Measure
Measurement of Gluten and Soy Antigen in Esophageal Mucosa
time frame: one year

Secondary Outcomes

Measure
Dilated intercellular spaces (spongiosis)
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion criteria: - Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors. - Patients previously diagnosed with Eosinophilic Esophagitis and are now in histologic remission due to treatment and have <15 eos hpf. Exclusion Criteria - Acute allergy to wheat or soy - Currently taking steroids - Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Additional Information

Official title Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
Principal investigator David Katzka, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.