The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults

Not Applicable

Completed

Conditions: Food Allergy

Interventions: Dietary Supplement: Dietary supplement

Registration Number: NCT01822353

Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

severe IgE-mediated milk allergy or
severe IgE-mediated egg allergy or
severe IgE-mediated nut allergy or
18-50 years

Exclusion Criteria

instable cerebrovascular or heart disease
active autoimmune disease or cancer
use of betablocker agents
poorly controlled asthma
FEV1 < 70% of the predicted

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nut allergy	Dietary supplement	Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.
Egg allergy	Dietary supplement	Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.
Milk allergy	Dietary supplement	Dietary supplement, milk in increasing dosages, delivered daily and orally.

Primary Outcome Measures

Name	Time	Method
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy	One year	Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.

Secondary Outcome Measures

Name	Time	Method
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?	One year	Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)
Effect of Therapy on Lung Function.	One year	Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?
Does Oral Immunotherapy Change Bronchial Hyperreactivity?	One year	Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?