Oral Immunotherapy in Food Allergy in Finland

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Immune System Diseases; Food Hypersensitivity; Anaphylaxis

Treatments: Dietary Supplement: Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02640014

U1020AL001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No 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).

Exclusion criteria

• Not willing to participate
• Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Study 1: Milk OIT follow up

Experimental group

Description:

Follow up on patient with severe milk allergy how have participated to milk OIT.

Treatment:

Dietary Supplement: Milk

Study 1: Follow up

No Intervention group

Description:

Follow up on patient with severe milk allergy how have not participated to milk OIT.