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Food Antigen in Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT02434705
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Other: Antigen (wheat base soy sauce) spray

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.

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eosinophilic Esophagitis patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434705


Contacts
Contact: Debra M. Geno, CCRP 507-538-0367 geno.debra@mayo.edu
Contact: Lori A. Kryzer 507-538-2403 kryzer.lori@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Crystal J Tholen, CRC    507-538-1361    tholen.crystal@mayo.edu   
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Crystal J Tholen, CRC    507-538-1361    tholen.crystal@mayo.edu   
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
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

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