An interventional study of Milk in Food Hypersensitivity, Immune System Diseases and Anaphylaxis, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Follow up on patient with severe milk allergy how have participated to milk OIT.
Dietary Supplement: Milk
Follow up on patient with severe milk allergy how have not participated to milk OIT.
Milk Oral immunotherapy
Long-term effectiveness as a measure of milk consumption (dl/day).
Consumption of milk (dl/day)
Time frame: Ten years
General health-related quality of life
To measure health-related quality of life by using a generic (Finnish 15-D questionnaire) before and one year after OIT.
Time frame: One year
Disease specific health-related quality of life
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.
Time frame: One year
Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).
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.
Time frame: One year
Incidence of Treatment - Emergent Adverse Events
Severe adverse events
Time frame: Ten years
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: cow's milk
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