Allergy Immunotherapy in the Management of Eosinophilic Esophagitis (AIMEE)

August 17, 2016 updated by: United States Naval Medical Center, San Diego

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after after starting allergy immunotherapy

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Eosinophilia change
Time Frame: 1 year
Absolute eosinophilic counts will be measured before and after intervention.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (ESTIMATE)

September 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCSD.2012.0148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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