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

The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated 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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• 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 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk allergy; Milk oral immunotherapy intervention for milk allergy	Dietary supplement: Oral immunotherapy; Milk, peanut or egg oral immunotherapy
Experimental: Peanut allergy; Peanut oral immunotherapy intervention for peanut allergy	Dietary supplement: Oral immunotherapy; Milk, peanut or egg oral immunotherapy
Experimental: Egg allergy; Egg oral immunotherapy intervention for egg allergy	Dietary supplement: Oral immunotherapy; Milk, peanut or egg oral immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desensitisation	Increase in tolerated dose of food compared to the pre-OIT, number of participants	1 year, through study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in worries associated with food allergy	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	1 year, through study completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	Follow-up of safety of OIT	1 year, through study completion
Decrease in allergen specific IgE values	Decrease in allergen specific IgE values	1 year, through study completion

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): March 11, 2023
• Study Completion (Actual): March 11, 2023

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: adult; milk; peanut; egg; oral immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Egg Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: HUS/486/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No