Oral Immunotherapy in Food Allergy in Finland

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Food Hypersensitivity, Immune System Diseases, Anaphylaxis

Intervention / Treatment
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* Dietary Supplement: Milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study 1: Milk OIT follow up<br>Follow up on patient with severe milk allergy how have participated to milk OIT. | Dietary Supplement: Milk<br>* Milk Oral immunotherapy<br>|
| No Intervention: Study 1: Follow up<br>Follow up on patient with severe milk allergy how have not participated to milk OIT. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food allergy, Health-related quality of life (HRQL), Quality-adjusted life-years (QALYs), Oral immunotherapy (OIT), Cow´s milk allergy (CMA), Milk oral immunotherapy (MOIT)