Oral Immunotherapy in Food Allergy in Finland

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02640014

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Food Hypersensitivity Immune System Diseases Anaphylaxis	Dietary Supplement: Milk	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Long-term effectiveness as a measure of milk consumption (dl/day). [Ten years]
Consumption of milk (dl/day)

Secondary Outcome Measures

General health-related quality of life [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 [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). [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 [Ten years]
Severe adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).