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Completed

NCT Number: NCT02227836

Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis

This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30) following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a standard clinically indicated Six Food Elimination Diet treatment completed. Patients will follow up with one of three investigators following the elimination diet who will be blinded to the results of the APT. During this visit responders and nonresponders will be identified and nonresponders will complete a directed elimination diet based on APT results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ages 18-90
  • Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
  • Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy

Exclusion criteria

  • Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
  • Topical swallowed steroids within 8 weeks of study enrollment
  • Dermatologic conditions precluding application of Finn chambers to the skin for APT
  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Treatment and study plan

Allergy Patch Testing

Device

Other names: APT, Patch testing, Allergy testing

Primary outcomes

  1. Sensitivity of Patch Testing

    Time frame: up to 120 hours after application of patch test

    Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study

Acronym: EoE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2014
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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