Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Biological: Allergy immunotherapy (allergy shots)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for care at Naval Medical Center San Diego Diagnosis of EoE (with or without GERD) Positive skin test to aeroallergen(s) Able to provide written informed consent prior to the conduct of any study related procedure Exclusion Criteria: All excluding conditions for Allergy immunotherapy (AIT) - pregnancy, severe asthma, uncontrolled asthma, taking a beta blocker, history of coronary artery disease. (Note: age is not typically an exclusion criteria for AIT, however this will be an adult only study). History of significant esophageal disease other than EoE (such as esophageal cancer, surgeries…) History of other systemic eosinophilic conditions (such as …) Subjects with controlled asthma on inhaled steroids at the time of diagnosis of EoE may be included , however if a subject develops new asthma or worsening asthma during the study requiring new initiation of inhaled steroids, they may be discontinued to avoid possible swallowing of the medication and treatment of their EoE. If subject is judged by the investigator as unlikely to understand the scope of the study and/or is unlikely to comply with the study procedures and visits. Is currently or has recently been on AIT (within the past year)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergy Immunotherapy Group<br>There is only one active experimental group as this is a pilot study comparing clinical/histologic/endoscopic changes before and after treatment. | Biological: Allergy immunotherapy (allergy shots)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic change | Subjects will be started on allergy immunotherapy. We will compare before and after pathology - changes in eosinophils per high power field in esophageal biopsy. | 1 year after after starting allergy immunotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic changes | Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic esophagitis, Environmental allergens, Allergy immunotherapy, Tolerance, Allergic rhinitis, Asthma, Seasonal variation