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

December 2, 2013 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients > 4 years old with IgE mediated allergy to cow;s milk, eggs or peanuts who completed an OIT program >6 months ago

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Completed OIT
Patients who completed OIT >6 months prior to enrollment
Dietary supplement: Allergenic food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Allergenic food consumption questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Yitzhak Katz, MD, Asaf Harofeh Medical enter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (ESTIMATE)

December 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 41/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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