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

Not Applicable
Completed
Conditions
Food Allergy
Interventions
Dietary Supplement: Oral immunotherapy
Registration Number
NCT03361072
Lead Sponsor
Helsinki University Central Hospital
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Peanut allergyOral immunotherapyPeanut oral immunotherapy intervention for peanut allergy
Egg allergyOral immunotherapyEgg oral immunotherapy intervention for egg allergy
Milk allergyOral immunotherapyMilk oral immunotherapy intervention for milk allergy
Primary Outcome Measures
NameTimeMethod
Desensitisation1 year, through study completion

Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants

Secondary Outcome Measures
NameTimeMethod
Worries Associated With Food Allergy1 year, through study completion

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

Trial Locations

Locations (1)

Helsinki University Central Hospital

🇫🇮

Helsinki, Finland

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