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Oral Immunotherapy in Food Allergy in Finland

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02640014
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Helsinki University Central Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mika J Mäkelä, MD, PhD
Principal Investigator Affiliation Chief Physician, Helsinki University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Hypersensitivity, Immune System Diseases, Anaphylaxis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Study 1: Milk OIT follow up

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

No Intervention: Study 1: Follow up

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

Interventions

Dietary Supplement: - Milk

Milk Oral immunotherapy

Contact a Trial Team

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International Sites

Helsinki, Finland

Status

Address

Helsinki University Central Hospital, Skin and Allergy Hospital

Helsinki, , 00029

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