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

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822353
• Other study ID #: HUS21813030112
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2017

Study information

• Verified date: January 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity

Intervention

Dietary Supplement:
• Dietary supplement
Milk, egg or nut oral immunotherapy

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.	How many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?	One year
Other	Effect of Treatment on Quality of Life	Quality of life is assessed by a questionnaire before and after immunotherapy (VAS scale on worries on allergy 0-100, 0 no worries, 100 maximal worries).	one year
Primary	Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy	Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.	One year
Secondary	Effect of Therapy on Lung Function.	Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?	One year
Secondary	Does Oral Immunotherapy Change Bronchial Hyperreactivity?	Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?	One year
Secondary	Does the Oral Immunotherapy Have en Effect on Airway Inflammation?	Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)	One year