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

NCT ID: NCT01999387

Last Updated: 2013-12-03

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

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Allergy

Keywords

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food consumption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Completed OIT

Patients who completed OIT \>6 months prior to enrollment

Allergenic food

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Allergenic food

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yitzhak Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf Harofeh Medical enter

Locations

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Asaf Harofeh Medical Center

Ẕerifin, Israel, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yitzhak Katz, MD

Role: CONTACT

Phone: 97289779820

Email: [email protected]

Arnon Elizur

Role: CONTACT

Phone: 97289779820

Email: [email protected]

Facility Contacts

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Arnon Elizur

Role: primary

Other Identifiers

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41/13

Identifier Type: -

Identifier Source: org_study_id