Oral Immunotherapy in Food Allergy in Finland

NCT ID: NCT02640014

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Food Hypersensitivity; Immune System Diseases; Anaphylaxis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study 1: Milk OIT follow up

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

Group Type: EXPERIMENTAL

Milk

Intervention Type: DIETARY_SUPPLEMENT

Milk Oral immunotherapy

Study 1: Follow up

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Milk

Milk Oral immunotherapy

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tiina Kauppila, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mika J Mäkelä, MD, PhD

Role: STUDY_DIRECTOR

Chief Physician, Helsinki University Hospital

Locations

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, , Finland

Countries

Finland

References

Kauppila TK, Hinkkanen V, Savinko T, Karisola P, Kukkonen AK, Paassilta M, Pelkonen AS, Makela MJ. Long-term changes in milk component immunoglobulins reflect milk oral immunotherapy outcomes in Finnish children. Allergy. 2023 Feb;78(2):454-463. doi: 10.1111/all.15479. Epub 2022 Aug 20.

Reference Type: DERIVED

PMID: 35969113 (View on PubMed)

Other Identifiers

U1020AL001

Identifier Type: -

Identifier Source: org_study_id