This trial is active, not recruiting.

Condition eosinophilic esophagitis
Treatment allergy patch testing
Sponsor Mayo Clinic
Start date August 2014
End date June 2017
Trial size 8 participants
Trial identifier NCT02227836, 14-002050


Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic Esophagitis?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Patients referred to Mayo Clinic Rochester with an establish diagnosis of EoE who 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.
allergy patch testing APT
Patient will undergo APT testing per the following protocol: 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back. Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits The patches will be removed at 48 hours, and results read at 72 hours after application. Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).

Primary Outcomes

Reliability of patch testing is defined by the elimination or change of eosinophils in the esophagus with the endoscopic biopsies.
time frame: basesline, six weeks, 10 weeks, 14, weeks, 18 weeks, 20 weeks, 22 weeks, 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study
Principal investigator Karthik Ravi, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.