Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts

Allergy Clinical Trial

— OIT followup  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999387
• Other study ID #: 41/13
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2013
• Last updated: December 2, 2013
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2013
• Source: Assaf-Harofeh Medical Center
• Contact: Yitzhak Katz, MD
• Phone: 97289779820
• Email: ykatz49[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts.

We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.

Description:

Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with ~500 patients so far. Patients with IgE-mediated food allergy that are >4 years old are eligible.

In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained.

Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 40 Years

Eligibility

Inclusion Criteria:

• age>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT >6 months ago

Exclusion Criteria:

• Non approval to participate

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Allergy

Intervention

Dietary Supplement:
• Allergenic food

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergenic food consumption questionnaire		6 months	No