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Allergy Immunotherapy in the Management of Eosinophilic Esophagitis (AIMEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685034
Recruitment Status : Withdrawn (Researcher deployed before approval)
First Posted : September 13, 2012
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Biological: Allergy immunotherapy ("allergy shots") Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Allergy Immunotherapy Group
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")

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Symptomatic changes [ Time Frame: 1 year ]
    Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy)

Other Outcome Measures:
  1. Endoscopic changes [ Time Frame: 1 year ]
    In addition to above, we will score their endoscopic findings before and after the intervention. The categories scored will include: 1. Pallor and diminished vascular markings 2. Furrowing 3. White plaques 4. Concentric rings or strictures. If 1 esophageal site is involved, 1 point will be given. If more than 1 site, 2 points allocated. If entire esophagus is involved, 3 points allocated and maximum score will be 12.

  2. Eosinophilia change [ Time Frame: 1 year ]
    Absolute eosinophilic counts will be measured before and after intervention.

  3. Adverse outcomes [ Time Frame: 1 year ]
    Any adverse events will be collected during the first year. Allergy immunotherapy has been used clinically for over 100 years. Local site reactions are common and expected, but we will monitor systemic reaction rates in this specific population and compare to known rates of reactions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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Responsible Party: United States Naval Medical Center, San Diego Identifier: NCT01685034    
Other Study ID Numbers: NMCSD.2012.0148
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by United States Naval Medical Center, San Diego:
Eosinophilic esophagitis
Environmental allergens
Allergy immunotherapy
Allergic rhinitis
Seasonal variation
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Immune System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs