Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis (EoE)

Mayo Clinic

Status: Completed

Conditions: Eosinophilic Esophagitis

Treatments: Device: Allergy Patch Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02227836

14-002050

UL1TR000135 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Allergy Patch Testing APT

Experimental group

Description:

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 and 120 hours after application * Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).

Treatment:

Device: Allergy Patch Testing