The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults

Study Overview
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Brief Summary
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The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.

Detailed Description
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30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.

Official Title
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The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults

Conditions
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Food Allergy

Intervention / Treatment
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* Dietary Supplement: Oral immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test Exclusion Criteria: instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers. poorly controlled asthma or FEV1 < 70% (FEV1< -2SD)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk allergy<br>Milk oral immunotherapy intervention for milk allergy | Dietary Supplement: Oral immunotherapy<br>* Milk, peanut or egg oral immunotherapy<br>|
| Experimental: Peanut allergy<br>Peanut oral immunotherapy intervention for peanut allergy | Dietary Supplement: Oral immunotherapy<br>* Milk, peanut or egg oral immunotherapy<br>|
| Experimental: Egg allergy<br>Egg oral immunotherapy intervention for egg allergy | Dietary Supplement: Oral immunotherapy<br>* Milk, peanut or egg oral immunotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desensitisation | Increase in tolerated dose of food compared to the pre-OIT, number of participants | 1 year, through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in worries associated with food allergy | Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT | 1 year, through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral immunotherapy, milk, peanut, egg, adult