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Food Antigen in Eosinophilic Esophagitis

NCT ID: NCT02434705

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2023-12-08

Brief Summary

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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

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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.

Conditions

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Eosinophilic Esophagitis

Keywords

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Eosinophilic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Antigen (wheat base soy sauce) spray

Intervention Type OTHER

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.

Interventions

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Antigen (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.

Intervention Type OTHER

Other Intervention Names

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Wheat based soy sauce

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Joseph A. Murray, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Murray, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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15-000883

Identifier Type: -

Identifier Source: org_study_id