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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Food Allergy

Treatments: Dietary Supplement: Oral immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03361072

HUS/486/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Milk allergy

Experimental group

Description:

Milk oral immunotherapy intervention for milk allergy

Treatment:

Dietary Supplement: Oral immunotherapy

Peanut allergy

Experimental group

Description:

Peanut oral immunotherapy intervention for peanut allergy

Treatment:

Dietary Supplement: Oral immunotherapy

Egg allergy

Experimental group

Description:

Egg oral immunotherapy intervention for egg allergy

Treatment:

Dietary Supplement: Oral immunotherapy