Oral Immunotherapy in Food Allergy in Finland

Helsinki University Central Hospital250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Food Hypersensitivity Immune System Diseases Anaphylaxis

Interventions

MilkDIETARY_SUPPLEMENT

Milk Oral immunotherapy

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Long-term effectiveness as a measure of milk consumption (dl/day).

Consumption of milk (dl/day)

Time frame: Ten years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: One year

Incidence of Treatment - Emergent Adverse Events

Severe adverse events

Time frame: Ten years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.