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

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allergy Patch Testing
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis focused on measuring Allergy Patch testing, Eosinophilic Esophagitis, EoE

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allergy Patch Testing APT

Arm 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2014
Last Updated
March 25, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02227836
Brief Title
Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis
Acronym
EoE
Official Title
Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Allergy Patch testing, Eosinophilic Esophagitis, EoE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergy Patch Testing APT
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Allergy Patch Testing
Other Intervention Name(s)
APT, Patch testing, Allergy testing
Primary Outcome Measure Information:
Title
Sensitivity of Patch Testing
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Ravi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29349695
Citation
Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis

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