Food Antigen in Eosinophilic Esophagitis
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Other: Antigen (wheat base soy sauce) spray
- Registration Number
- NCT02434705
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Antigen (wheat base soy sauce) spray Antigen (wheat base soy sauce) spray 1. 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. 2. During the endoscopy two biopsies will be taken from the esophageal body, 10 cm above the gastroesophageal junction. 3. 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.
- Primary Outcome Measures
Name Time Method Measurement of Gluten and Soy Antigen in Esophageal Mucosa one year Cryosectioning of the frozen esophageal tissue will then be done for immunofluorescent staining to determine the distribution/localization of different cells and dietary proteins We will use anti-gliadin (Biorbyt catalog # orb157160)and anti-soy (LifeSpan Biosciences Catalog # LS-C132165-100)antibodies against cell surface markers as well as dietary proteins/peptides tagged with different fluorochromes to achieve this.
- Secondary Outcome Measures
Name Time Method Dilated intercellular spaces (spongiosis) one year Is graded on the basis of the worst area, using a 0-4+ scale \[3\]. DIS grading was assessed by the appearance of the tight junctions seen on biopsy and the degree of widening between epithelial cells . Grade 0: no intercellular space widening and intact tight junctions. Grade 1: mild widening of intercellular spaces with attenuation and prominence of tight junctions. Grade 2: Further widening of intercellular space with some disruption of tight junctions. Grade 3: complete disruption of tight junctions with further widening of intercellular spaces, forming small "lakes" in the epithelium. Grade 4: Coalescence of epithelial lakes.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States