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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02640014
Other study ID # U1020AL001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 2021

Study information

Verified date February 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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


Intervention

Dietary Supplement:
Milk
Milk Oral immunotherapy

Locations

Country Name City State
Finland Helsinki University Central Hospital, Skin and Allergy Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long-term effectiveness as a measure of milk consumption (dl/day). Consumption of milk (dl/day) Ten years
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary Incidence of Treatment - Emergent Adverse Events Severe adverse events Ten years
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