Oral Immunotherapy in Food Allergy in Finland
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|ClinicalTrials.gov Identifier: NCT02640014|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2015
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Food Hypersensitivity Immune System Diseases Anaphylaxis||Dietary Supplement: Milk||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
- Long-term effectiveness as a measure of milk consumption (dl/day). [ Time Frame: Ten years ]Consumption of milk (dl/day)
- 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.
- 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.
- 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.
- Incidence of Treatment - Emergent Adverse Events [ Time Frame: Ten years ]Severe adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640014
|Helsinki University Central Hospital, Skin and Allergy Hospital|
|Helsinki, Finland, 00029|
|Study Director:||Mika J Mäkelä, MD, PhD||Chief Physician, Helsinki University Hospital|