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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1: Milk OIT follow up | Experimental | Follow up on patient with severe milk allergy how have participated to milk OIT. |
|
| Study 1: Follow up | No Intervention | Follow up on patient with severe milk allergy how have not participated to milk OIT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk | Dietary Supplement | Milk Oral immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term effectiveness as a measure of milk consumption (dl/day). | Consumption of milk (dl/day) | Ten years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Disease specific health-related quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika J Mäkelä, MD, PhD | Chief Physician, Helsinki University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Skin and Allergy Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35969113 | Derived | Kauppila TK, Hinkkanen V, Savinko T, Karisola P, Kukkonen AK, Paassilta M, Pelkonen AS, Makela MJ. Long-term changes in milk component immunoglobulins reflect milk oral immunotherapy outcomes in Finnish children. Allergy. 2023 Feb;78(2):454-463. doi: 10.1111/all.15479. Epub 2022 Aug 20. |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D007154 | Immune System Diseases |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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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). | 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 | Severe adverse events | Ten years |
| D005502 |
| Food |
| D019602 | Food and Beverages |