Food HypersensitivityNCT02640014
Oral Immunotherapy in Food Allergy in Finland
A study testing Milk in people with Food Hypersensitivity and Immune System Diseases, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Food Hypersensitivity, Immune System Diseases, Anaphylaxis
- What is being tested?
- Milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2015to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Not willing to participate
- Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, 00029
About this study
Official title: Specific Oral Immunotherapy in Food Allergy - Real-life Long-term Follow up (After Milk Oral Immunotherapy), Effect on Health-related Quality of Life and Cost-utility Analyses
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.
Read the 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
- Being tested
- Milk
- Keywords
- Food allergy, Health-related quality of life (HRQL), Quality-adjusted life-years (QALYs), Oral immunotherapy (OIT), Cow´s milk allergy (CMA), Milk oral immunotherapy (MOIT)
- Medical subject headings
- Food Hypersensitivity, Immune System Diseases, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkDietary supplement
Milk Oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Milk OIT follow up | Experimental | Follow up on patient with severe milk allergy how have participated to milk OIT. Receives: Dietary Supplement: Milk |
| Study 1: Follow up | No intervention | Follow up on patient with severe milk allergy how have not participated to milk OIT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term effectiveness as a measure of milk consumption (dl/day).
Consumption of milk (dl/day)
Measured: Ten years
Secondary outcomes (4)
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.
Measured: One year
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.
Measured: One year
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.
Measured: One year
Incidence of Treatment - Emergent Adverse Events
Severe adverse events
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion28 Sep 2022
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiina Kauppila, MD, Helsinki University Central Hospital
- Investigators
- Mika J Mäkelä, MD, PhD, Study director, Chief Physician, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640014
- Sponsor's protocol ID
- U1020AL001
- Status last verified
- May 2026
- First submitted
- 17 Dec 2015
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35969113
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Oral Immunotherapy in Food Allergy - Real-life Long-term Follow up (After Milk Oral Immunotherapy), Effect on Health-related Quality of Life and Cost-utility Analyses
- ClinicalTrials.gov ID
- NCT02640014
- Acronym / sponsor ID
- U1020AL001
- Conditions
- Food Hypersensitivity, Immune System Diseases, Anaphylaxis
- Keywords
- Food allergy, Health-related quality of life (HRQL), Quality-adjusted life-years (QALYs), Oral immunotherapy (OIT), Cow´s milk allergy (CMA), Milk oral immunotherapy (MOIT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1: Milk OIT follow up | Experimental | Dietary Supplement: MilkFollow up on patient with severe milk allergy how have participated to milk OIT. |
| Study 1: Follow up | No intervention | –Follow up on patient with severe milk allergy how have not participated to milk OIT. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Not willing to participate
- Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilkMilk Oral immunotherapy | Dietary supplement | Study 1: Milk OIT follow up |
Primary outcome
Long-term effectiveness as a measure of milk consumption (dl/day).
Time frame: Ten years
Consumption of milk (dl/day)
4 secondary outcomes
General health-related quality of life
Time frame: One year
Disease specific health-related quality of life
Time frame: One year
Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).
Time frame: One year
Incidence of Treatment - Emergent Adverse Events
Time frame: Ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 35969113Kauppila 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mika J Mäkelä, MD, PhD study director
Chief Physician, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk in people with Food Hypersensitivity and Immune System Diseases, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term effectiveness as a measure of milk consumption (dl/day). (time frame: Ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02640014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.