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NCT Number: NCT01822353

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?

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Key information

Conditions

Food Allergy Egg Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity Nut Hypersensitivity Nut and Peanut Hypersensitivity

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:

  • 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.
  • 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.
  • 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Supplement

Dietary Supplement

Milk, egg or nut oral immunotherapy

Other names: Milk, Egg protein, Nut cream

Primary outcomes

  1. Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy

    Time frame: 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 outcomes

  1. Effect of Therapy on Lung Function.

    Time frame: One year

    Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?

  2. Does Oral Immunotherapy Change Bronchial Hyperreactivity?

    Time frame: One year

    Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?

  3. Does the Oral Immunotherapy Have en Effect on Airway Inflammation?

    Time frame: One year

    Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)

Other outcomes

  1. Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.

    Time frame: One year

    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?

  2. Effect of Treatment on Quality of Life

    Time frame: one year

    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).

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 2, 2013
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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