Oral Immunotherapy in Food Allergy in Finland

May 4, 2026 updated by: Tiina Kauppila, MD, Helsinki University Central Hospital

Specific Oral Immunotherapy in Food Allergy - Real-life Long-term Follow up (After Milk Oral Immunotherapy), Effect on Health-related Quality of Life and Cost-utility Analyses

The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way to increase the unresponsiveness in severe food allergies. However little is known about it´s long-term outcomes, immunological mechanisms and there are no previous studies about cost-utility of OIT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the present study is to examine the outcomes of the food oral immunotherapy on patients with severe food allergy in the three different subprojects:

Study 1: Long-term follow up after milk oral immunotherapy. The measured outcomes are long-term effectiveness (e.g. health-related quality of life), safety of desensitization and immunological changes.

Study 2: Measure health-related quality of life with disease-specific and generic questionnaire. The aim of this study is to define the suitability of the FAQLQ and the 15-D questionnaires for the Finnish food allergic patients. Another purpose of this study is to examine the relationship between FAQLQ and 15-D questionnaires.

Study 3: QALYs. This is called the cost-utility analyses and QALYs and its purpose is to calculate the cost of OIT and to define the cost-effectiveness of OIT by measuring QALYs. To our knowledge this will be the first pilot study to define the QALYs in food oral immunotherapy. The aim is to have 50-100 patients. The literature in other areas of medicine 50-100 patients in QALY-publishing is quite plain.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital, Skin and Allergy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Study 1: All the children have been eligible to participate milk OIT during the years 2005-2015.
  • Study 2 + 3: Patients will start OIT treatment (to milk / egg / peanut).

Exclusion Criteria:

  • Not willing to participate
  • Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study 1: Milk OIT follow up
Follow up on patient with severe milk allergy how have participated to milk OIT.
Dietary supplement: Milk
Milk Oral immunotherapy
No Intervention: Study 1: Follow up
Follow up on patient with severe milk allergy how have not participated to milk OIT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term effectiveness as a measure of milk consumption (dl/day).
Time Frame: Ten years
Consumption of milk (dl/day)
Ten years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General health-related quality of life
Time Frame: One year
To measure health-related quality of life by using a generic (Finnish 15-D questionnaire) before and one year after OIT.
One year
Disease specific health-related quality of life
Time Frame: One year
To measure health-related quality of life by using a disease specific questionnaires (Food Allergy Quality of Life Questionnaires, FAQLQ) before and one year after OIT.
One year
Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).
Time Frame: One year
A Pilot study to define the cost of OIT and define the cost of quality-adjusted life-years (QALYs) with generic health-realted quality of life scale 15-D-questionnaire.
One year
Incidence of Treatment - Emergent Adverse Events
Time Frame: Ten years
Severe adverse events
Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Mika J Mäkelä, MD, PhD, Chief Physician, Helsinki University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimated)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1020AL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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