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

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

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?

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Dietary supplement: Dietary supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Milk allergy; Dietary supplement, milk in increasing dosages, delivered daily and orally.	Dietary supplement: Dietary supplement; Milk, egg or nut oral immunotherapy; Other Names: Milk; Egg protein; Nut cream
EXPERIMENTAL: Egg allergy; Dietary supplement, egg protein given in increasing dosages, delivered daily and orally.	Dietary supplement: Dietary supplement; Milk, egg or nut oral immunotherapy; Other Names: Milk; Egg protein; Nut cream
EXPERIMENTAL: Nut allergy; Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally.	Dietary supplement: Dietary supplement; Milk, egg or nut oral immunotherapy; Other Names: Milk; Egg protein; Nut cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Mika J Mäkelä, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (ESTIMATE): April 2, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: food allergy; egg allergy; nut allergy; milk allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity
• Other Study ID Numbers: HUS21813030112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED