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

• Conditions: Allergy
• Interventions: Dietary Supplement: Allergenic food

• Registration Number: NCT01999387
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-02
• Last Update Submitted: 2013-12-02
• Study First Posted: 2013-12-03
• Last Update Posted: 2013-12-03
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Completed OIT	Allergenic food	Patients who completed OIT \>6 months prior to enrollment

Primary Outcome Measures

Name	Time	Method
Allergenic food consumption questionnaire	6 months

Trial Locations

Locations (1)

Asaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel