Oral Immunotherapy in Food Allergy in Finland

Not Applicable

• Conditions: Food Hypersensitivity; Anaphylaxis; Immune System Diseases
• Interventions: Dietary Supplement: Milk

• Registration Number: NCT02640014
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study 1: Milk OIT follow up	Milk	Follow up on patient with severe milk allergy how have participated to milk OIT.

Primary Outcome Measures

Name	Time	Method
Long-term effectiveness as a measure of milk consumption (dl/day).	Ten years	Consumption of milk (dl/day)

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
Incidence of Treatment - Emergent Adverse Events	Ten years	Severe adverse events

Trial Locations

Locations (1)

Helsinki University Central Hospital, Skin and Allergy Hospital; 🇫🇮 Helsinki, Finland