Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT02434705
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2015-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Antigen in Eosinophilic Esophagitis
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EoE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: