Oral Immunotherapy in Food Allergy in Finland
Primary Purpose
Food Hypersensitivity, Immune System Diseases, Anaphylaxis
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Milk
Sponsored by
About this trial
This is an interventional treatment trial for Food Hypersensitivity focused on measuring 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)
Eligibility Criteria
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.
Sites / Locations
- Helsinki University Central Hospital, Skin and Allergy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study 1: Milk OIT follow up
Study 1: Follow up
Arm Description
Follow up on patient with severe milk allergy how have participated to milk OIT.
Follow up on patient with severe milk allergy how have not participated to milk OIT.
Outcomes
Primary Outcome Measures
Long-term effectiveness as a measure of milk consumption (dl/day).
Consumption of milk (dl/day)
Secondary Outcome Measures
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.
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.
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.
Incidence of Treatment - Emergent Adverse Events
Severe adverse events
Full Information
NCT ID
NCT02640014
First Posted
December 17, 2015
Last Updated
February 19, 2021
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02640014
Brief Title
Oral Immunotherapy in Food Allergy in Finland
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity, Immune System Diseases, Anaphylaxis
Keywords
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study 1: Milk OIT follow up
Arm Type
Experimental
Arm Description
Follow up on patient with severe milk allergy how have participated to milk OIT.
Arm Title
Study 1: Follow up
Arm Type
No Intervention
Arm Description
Follow up on patient with severe milk allergy how have not participated to milk OIT.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk
Intervention Description
Milk Oral immunotherapy
Primary Outcome Measure Information:
Title
Long-term effectiveness as a measure of milk consumption (dl/day).
Description
Consumption of milk (dl/day)
Time Frame
Ten years
Secondary Outcome Measure Information:
Title
General health-related quality of life
Description
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
Title
Disease specific health-related quality of life
Description
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
Title
Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).
Description
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
Title
Incidence of Treatment - Emergent Adverse Events
Description
Severe adverse events
Time Frame
Ten years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika J Mäkelä, MD, PhD
Organizational Affiliation
Chief Physician, Helsinki University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Central Hospital, Skin and Allergy Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Immunotherapy in Food Allergy in Finland
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