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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 : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Tracking Information
First Submitted Date April 30, 2015
First Posted Date May 5, 2015
Last Update Posted Date May 6, 2020
Study Start Date April 2015
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 4, 2015)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Food Antigen in Eosinophilic Esophagitis
Official Title Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Eosinophilic Esophagitis patients
Condition Eosinophilic Esophagitis
Intervention 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
Study Groups/Cohorts 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.
Intervention: Other: Antigen (wheat base soy sauce) spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 4, 2015)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Crystal J Lavey, CRC 507-538-1361 Lavey.Crystal@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02434705
Other Study ID Numbers 15-000883
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party David A. Katzka, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: David Katzka, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2020