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Food Antigen in Eosinophilic Esophagitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02434705
Acronym
EoE
Enrollment
72
Registered
2015-05-05
Start date
2015-04-01
Completion date
2023-12-08
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic

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.

Interventions

OTHERAntigen (wheat base soy sauce) spray

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Gluten and Soy Antigen in Esophageal Mucosaone yearCryosectioning 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

MeasureTime frameDescription
Dilated intercellular spaces (spongiosis)one yearIs 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026