Eosinophilic Esophagitis
Conditions
Keywords
Eosinophilic esophagitis, Environmental allergens, Allergy immunotherapy, Tolerance, Allergic rhinitis, Asthma, Seasonal variation
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 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.
Interventions
BIOLOGICALAllergy immunotherapy (allergy shots)
Sponsors
United States Naval Medical Center, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologic change | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic changes | 1 year | Symptom questionaire will be assessed before intervention and after (about 1 year after being on allergy immunotherapy) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic changes | 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. |
| Eosinophilia change | 1 year | Absolute eosinophilic counts will be measured before and after intervention. |
| Adverse outcomes | 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. |
Outcome results
None listed