Eosinophilic Esophagitis
Conditions
Keywords
Allergy Patch testing, Eosinophilic Esophagitis, EoE
Brief summary
This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.
Detailed 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.
Interventions
DEVICEAllergy Patch Testing
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Patch Testing | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 and 120 hours after application.
* Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles). | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Allergy Patch Testing APT | — |
|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 11 | — |
| Allergic history | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Sensitivity of Patch Testing
Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
Time frame: up to 120 hours after application of patch test
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Allergy Patch Testing APT | Sensitivity of Patch Testing | 1 Participants |