Skip to main content
OpenTrials
Completed

NCT Number: NCT03361072

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

oral immunotherapy

Dietary Supplement

Milk, peanut or egg oral immunotherapy

Primary outcomes

  1. Desensitisation

    Time frame: 1 year, through study completion

    Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants

Secondary outcomes

  1. Worries Associated With Food Allergy

    Time frame: 1 year, through study completion

    Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT

Other outcomes

  1. Number of Participants With Treatment-related Adverse Events

    Time frame: 1 year, through study completion

    Follow-up of safety of OIT, Number of participants with treatment-related adverse events

  2. Decrease in Allergen Specific IgE Values

    Time frame: 1 year, through study completion

    Allergen specific IgE values before OIT and after OIT (kU/l)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2017
Registry last updated
May 9, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.