Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

NCT00123656

Esophagitis

COMPLETED PHASE2

Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

NCT00895817

Eosinophilic Esophagitis

COMPLETED NA

Eosinophilic Esophagitis Clinical Therapy Comparison Trial

NCT01821898

Eosinophilic Esophagitis

TERMINATED PHASE2

Risk Factors and Biomarkers for Diagnosis and Treatment of EoE

NCT01988285

Eosinophilic Esophagitis

ACTIVE_NOT_RECRUITING

Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids

NCT05246085

Eosinophilic Esophagitis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eosinophilic Esophagitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Allergy immunotherapy ("allergy shots")

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allergy immunotherapy ("allergy shots")

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No