Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227836
• Other study ID #: 14-002050
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: March 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• Allergy Patch Testing

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	up to 120 hours after application of patch test

External Links

•   Mayo Clinic Clinical Trials