Food Antigen in Eosinophilic Esophagitis
This trial is active, not recruiting.
|Treatment||antigen (wheat base soy sauce) spray|
|Start date||April 2015|
|End date||April 2017|
|Trial size||20 participants|
|Trial identifier||NCT02434705, 15-000883|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
Measurement of Gluten and Soy Antigen in Esophageal Mucosa
time frame: one year
Dilated intercellular spaces (spongiosis)
time frame: one year
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
|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.|
Call for more information