The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity
Study type: Interventional

Summary: 
      In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old
      children is 9%, and the most common allergen is milk. The overall food allergy has been
      reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood.
      In addition, it predicts later development of allergic disease such as asthma. Most of the
      egg and milk allergy is transient and disappears in childhood. Currently, the standard of
      care for food allergy includes strict allergen avoidance. However, oral immunotherapy has
      been under investigation in children milk, egg, and wheat allergy. Previously, induction of
      clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3
      to 13 years. In adults, strict avoidance is still the standard care but there is also growing
      interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.

      The investigators aim to analyse the results of per oral immunotherapy treatment in severe
      IgE-mediated 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?
    

Detailed description: 
      Up to 100 subjects are studied. All subjects are adults having no other severe chronic
      diseases. The subjects belong to four different groups:

        1. 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.

        2. 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.

        3. 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.

        4. 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk
           hyposensitisation treatment.

      The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg,
      milk and nut 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 bronchodilatation test, fractional exhaled nitric oxide and a methacholine
      challenge before and a year after oral immunotherapy. Those with test results diagnostic for
      asthma are treated with asthma medication before hyposensitisation treatment is started.

      Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune
      disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or
      FEV1 < 70% are not tolerated.

      In oral immunotherapy, increasing doses are given first observed, and then daily at home. If
      the subject does not tolerate a given dose and symptoms are mild, then that dose or the
      previously tolerated one is repeated, and the protocol proceeds as outlined. If the subject
      experiences significant symptoms, then the protocol is stopped, and the highest tolerated
      dose is used as the starting daily one.
    

Intervention name(s): Dietary supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Milk, egg or nut oral immunotherapy
Other intervention name(s): Milk; Egg protein; Nut cream
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: food allergy; milk allergy; egg allergy; nut allergy