Allergy Immunotherapy in the Management of Eosinophilic Esophagitis

NCT01685034 | Withdrawn DMC

• 1 other identifier: NMCSD.2012.0148
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic esophagitis; Environmental allergens; Allergy immunotherapy; Tolerance; Allergic rhinitis; Asthma; Seasonal variation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptomatic changes

  1 year

Other Outcomes (3)

• Endoscopic changes

  1 year

• Eosinophilia change

  1 year

• Adverse outcomes

  1 year

Study Arms (1)

Allergy Immunotherapy Group

EXPERIMENTAL

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")

Interventions

Allergy immunotherapy ("allergy shots") BIOLOGICAL

Allergy Immunotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Related Publications (7)

• Almansa C, Krishna M, Buchner AM, Ghabril MS, Talley N, DeVault KR, Wolfsen H, Raimondo M, Guarderas JC, Achem SR. Seasonal distribution in newly diagnosed cases of eosinophilic esophagitis in adults. Am J Gastroenterol. 2009 Apr;104(4):828-33. doi: 10.1038/ajg.2008.169. Epub 2009 Feb 24.

  PMID: 19240704 BACKGROUND

• Simon D, Marti H, Heer P, Simon HU, Braathen LR, Straumann A. Eosinophilic esophagitis is frequently associated with IgE-mediated allergic airway diseases. J Allergy Clin Immunol. 2005 May;115(5):1090-2. doi: 10.1016/j.jaci.2005.01.017. No abstract available.

  PMID: 15867873 BACKGROUND

• Mishra A, Hogan SP, Brandt EB, Rothenberg ME. An etiological role for aeroallergens and eosinophils in experimental esophagitis. J Clin Invest. 2001 Jan;107(1):83-90. doi: 10.1172/JCI10224.

  PMID: 11134183 BACKGROUND

• Moawad FJ, Veerappan GR, Lake JM, Maydonovitch CL, Haymore BR, Kosisky SE, Wong RK. Correlation between eosinophilic oesophagitis and aeroallergens. Aliment Pharmacol Ther. 2010 Feb 15;31(4):509-15. doi: 10.1111/j.1365-2036.2009.04199.x. Epub 2009 Nov 19.

  PMID: 19925501 BACKGROUND

• Penfield JD, Lang DM, Goldblum JR, Lopez R, Falk GW. The role of allergy evaluation in adults with eosinophilic esophagitis. J Clin Gastroenterol. 2010 Jan;44(1):22-7. doi: 10.1097/MCG.0b013e3181a1bee5.

  PMID: 19564792 BACKGROUND

• Onbasi K, Sin AZ, Doganavsargil B, Onder GF, Bor S, Sebik F. Eosinophil infiltration of the oesophageal mucosa in patients with pollen allergy during the season. Clin Exp Allergy. 2005 Nov;35(11):1423-31. doi: 10.1111/j.1365-2222.2005.02351.x.

  PMID: 16297137 BACKGROUND

• Fogg MI, Ruchelli E, Spergel JM. Pollen and eosinophilic esophagitis. J Allergy Clin Immunol. 2003 Oct;112(4):796-7. doi: 10.1016/s0091-6749(03)01715-9. No abstract available.

  PMID: 14564365 BACKGROUND

Related Links

• American Partnership for Eosinophilic Disorders

MeSH Terms

Conditions

Eosinophilic Esophagitis; Rhinitis, Allergic; Asthma

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 13, 2012
• Last Updated: August 19, 2016

Record last verified: 2016-08