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Food Antigen in Eosinophilic Esophagitis (EoE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02434705
First received: April 30, 2015
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Eosinophilic Esophagitis Other: Antigen (wheat base soy sauce) spray Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by David A. Katzka, Mayo Clinic:

Primary Outcome Measures:
  • Measurement of Gluten and Soy Antigen in Esophageal Mucosa [ Time Frame: 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:
  • Dilated intercellular spaces (spongiosis) [ Time Frame: 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.


Estimated Enrollment: 20
Study Start Date: April 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Other Name: Wheat based soy sauce

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02434705

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Katzka, MD Mayo Clinic
  More Information

Responsible Party: David A. Katzka, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02434705     History of Changes
Other Study ID Numbers: 15-000883
Study First Received: April 30, 2015
Last Updated: July 19, 2016

Keywords provided by David A. Katzka, Mayo Clinic:
Eosinophilic

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2017