Clinical trial NCT03361072: The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
Official title: The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: oral immunotherapy
milk
peanut
egg
adult
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Desensitisation
timeFrame: 1 year, through study completion
Secondary outcomes:
measure: Worries Associated With Food Allergy
timeFrame: 1 year, through study completion
Other outcomes:
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 1 year, through study completion
measure: Decrease in Allergen Specific IgE Values
timeFrame: 1 year, through study completion
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Paula Kauppi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: