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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02227836
First received: August 26, 2014
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
Can allergy patch test (APT) predict of dietary therapy in patients with Eosinophilic Esophagitis?

Condition Intervention
Eosinophilic Esophagitis
Device: Allergy Patch Testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]
    As a pilot, 20 patients will be studied to determine the reliability of the allergy patch test (APT) to predict dietary therapy. Reliability of the patch test and dietary therapy will be defined by the endoscopy biopsies.


Enrollment: 8
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allergy Patch Testing APT
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.
Device: Allergy Patch Testing

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).
Other Names:
  • APT
  • Patch testing
  • Allergy testing

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02227836

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Karthik Ravi, MD Mayo Clinic
  More Information

Responsible Party: Karthik Ravi, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02227836     History of Changes
Other Study ID Numbers: 14-002050
Study First Received: August 26, 2014
Last Updated: September 12, 2016

Keywords provided by Mayo Clinic:
Allergy Patch testing
Eosinophilic Esophagitis
EoE

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 25, 2017