The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk and Nut Allergy in Adults
Phase: NA
Conditions: Food Allergy
Sponsor: Helsinki University Central Hospital

 
 
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1
Paula Kauppi  
 
 
 
 
Study protocol  
 
 
 
 
19 Oct 2012 
 
 
 
 
- The effect of per oral immunotherapy treatment in severe IgE mediated 
egg, milk and nut allergy in adults. 
 
NCT01822353 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
2
2
 
 
Paula Kauppi  
 
 
 
 
Study protocol  
 
 
 
 
19 Oct 2012 
 
 
 
 
- The effect of per oral immunotherapy treatment in severe IgE mediated 
egg, milk and nut allergy in adults. 
 
NCT01822353 
 
Summary 
 
Prospective study on per oral immunotherapy treatment in IgE mediated egg, milk and nut 
allergy in adults (18-50- year olds).   
 
1. Aims  
 
We aim to analyse the results of per oral immunotherapy treatment in severe egg, milk and 
nut allergy in adults.  
 
 
Could severe egg, milk and nut allergy be treated with oral immunotherapy 
treatment in stead of total allergen avoidance and could desensitization thus be 
achieved? 
 
 
 
2. Study plan 
 
2.1. Subjects 
 
We study up to 90 subjects. All subjects are adults having no other severe chronic diseases. 
The subjects belong to four  different groups: 
 
 
(a) 
30 18-50 year olds who start per oral immunotherapy treatment in severe egg 
allergy. 
 
(b) 
30  18-50 year olds who start per oral immunotherapy treatment in severe milk 
allergy. 
 

 
 
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(c) 
30 18-50 year olds who start per oral immunotherapy treatment in severe nut 
allergy. 
 
 
The diagnosis of milk or egg allergy is verified with positive history, skin prick test, 
allergen specific IgE antibodies. In addition, food allergy is verified with an allergen 
specific challenge test.  
 
Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and 
mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and 
other asthma medication is allowed. Atopic subjects may have additional skin symptoms. 
Quality of life, anxiety and patient history data is collected by questionnaires. All patients 
undergo a spirometry with a bronchodilatator test, exhaled nitric oxide and a methacholine 
challenge before and a year after oral immunotherapy. Those with test results diagnostic for 
asthma (FEV1 response in a bronchodilator test > 12%/200ml and/ or PD20 <600 µg/ml 
methacholine in methacholine provocation test) are treated with asthma medication before 
hyposensibilisation treatment is started.   
 
Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune 
disease or cancer, or use of betablocking agents. In addition, poorly controlled asthma or 
FEV1 < 70% are not tolerated.  
 
 
 
2.2. Allergen specific challenge test 
 
Increasing doses are given every 60 minutes during the food allergen challenge. After the 
last dose, patients are observed at least for 2 hours. The protocol is done in a double-blind 
manner (day A, day B) in peanut and egg allergy and in one-day open manner in milk 
allergy. 
 
2.3. Study protocol  
Increasing doses are given daily. The first dose is given at the hospital and observed. Pre-
specified other doses are also given observed at the hospital but otherwise oral food 
immunotherapy is continued at home.  
 
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.  
 
After escalating doses of allergen during the first phase of oral immunotherapy, the 
treatment is continued with the highest tolerated maintenance dose until one year of 
therapy. Spirometry with a bronchodilatator test, exhaled nitric oxide, a methacholine 
challenge and immunological parameters are studied a year after oral immunotherapy.  
 

 
 
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2.4. Immunological parameters  
Serum samples are taken for allergen speficic and allergen component evaluation (IgE) 
before oral immunotherapy and at one year after starting the therapy.