Clinical Trial: Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis

Brief Summary:

Eosinophilic esophagitis (EoE) is a disease that has increased in incidence over the past decade that affects males predominantly, and in adults, is characterized by heartburn, dysphagia, strictures and food impactions. These symptoms may require emergent endoscopic removal of foods and esophageal dilations due to remodeling causing significant impairment in quality of life. Treatment options are limited and often not well tolerated or effective. There is poor understanding of the natural history and long term prognosis. It has been associated with allergic sensitization; a high percentage of affected individuals having associated atopy and current literature demonstrates a seasonal distribution of incidence and severity of symptoms. Allergy immunotherapy (AIT) is a well established and effective treatment for allergic rhinitis and asthma which can induce tolerance to environmental allergens.

Given the efficacy of AIT and the association of aeroallergen sensitization and even seasonal variation of EoE symptoms, we hypothesized that AIT may be a treatment option for patients with EoE.


Detailed Summary:

Purpose: To evaluate the role of allergy AIT in the management of EoE.

Research design: Patients with EoE and aeroallergen sensitization will be offered AIT as a treatment modality for EoE. They will be evaluated by questionnaire, laboratory tests, endoscopy and biopsy before and after treatment to determine if there is clinical, laboratory, endoscopic and histologic changes in their EoE.


Sponsor: United States Naval Medical Center, San Diego

Current Primary Outcome: Histologic change [ Time Frame: 1 year after after starting allergy immunotherapy ]

Subjects will be started on allergy immunotherapy. We will compare before and after pathology - changes in eosinophils per high power field in esophageal biopsy.


Original Primary Outcome: Same as current

Current Secondary Outcome: Symptomatic changes [ Time Frame: 1 year ]

Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy)


Original Secondary Outcome: Same as current

Information By: United States Naval Medical Center, San Diego

Dates:
Date Received: September 5, 2012
Date Started:
Date Completion:
Last Updated: August 17, 2016
Last Verified: August 2016