Food Antigen in Eosinophilic Esophagitis (EoE)
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|ClinicalTrials.gov Identifier: NCT02434705|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment|
|Eosinophilic Esophagitis||Other: Antigen (wheat base soy sauce) spray|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||November 2022|
Antigen (wheat base soy sauce) spray
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
- 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.
- Dilated intercellular spaces (spongiosis) [ Time Frame: one year ]Is graded on the basis of the worst area, using a 0-4+ scale . 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.
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David Katzka, MD||Mayo Clinic|