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NCT Number: NCT02640014

Oral Immunotherapy in Food Allergy in Finland

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.

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Key information

Conditions

Food Hypersensitivity Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Milk

Dietary Supplement

Milk Oral immunotherapy

Primary outcomes

  1. Long-term effectiveness as a measure of milk consumption (dl/day).

    Time frame: Ten years

    Consumption of milk (dl/day)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Incidence of Treatment - Emergent Adverse Events

    Time frame: Ten years

    Severe adverse events

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Dec 28, 2015
Registry last updated
May 5, 2026

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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