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Food Antigen in Eosinophilic Esophagitis (EoE)

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Mayo Clinic

Status

Completed

Conditions

Eosinophilic Esophagitis

Treatments

Other: Antigen (wheat base soy sauce) spray

Study type

Observational

Funder types

Other

Identifiers

NCT02434705
15-000883

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

72 participants in 1 patient group

Antigen (wheat base soy sauce) spray
Description:
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.
Treatment:
Other: Antigen (wheat base soy sauce) spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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