Food AllergyNCT03361072
The Effect of Per Oral Immunotherapy in Severe Milk, Peanut and Egg Allergy in Adults
A study testing Oral immunotherapy in people with Food Allergy, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 3 Aug 2017to 11 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test
Who cannot join
- instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers.
- poorly controlled asthma or FEV1 < 70% (FEV1< -2SD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults
The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.
Read the detailed description
30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.
- Conditions
- Food Allergy
- Being tested
- Oral immunotherapy
- Keywords
- oral immunotherapy, milk, peanut, egg, adult
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunotherapyDietary supplement
Milk, peanut or egg oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Milk allergy | Experimental | Milk oral immunotherapy intervention for milk allergy Receives: Dietary Supplement: Oral immunotherapy |
| Peanut allergy | Experimental | Peanut oral immunotherapy intervention for peanut allergy Receives: Dietary Supplement: Oral immunotherapy |
| Egg allergy | Experimental | Egg oral immunotherapy intervention for egg allergy Receives: Dietary Supplement: Oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitisation
Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants
Measured: 1 year, through study completion
Secondary outcomes (1)
Worries Associated With Food Allergy
Quality of life and reported concerns and worries associated with food allergy using a VAS scale (visual analogue scale) from 0 (no worries) to 100 mm (maximal worries) before OIT and at one year after OIT
Measured: 1 year, through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start3 Aug 2017
- Primary completion11 Mar 2023
- Study completion11 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Food AllergyStudies 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
- Model description
- Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Kauppi, MD, PhD, Helsinki University Central Hospital
- Investigators
- Paula Kauppi, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361072
- Sponsor's protocol ID
- HUS/486/2017
- Status last verified
- May 2025
- First submitted
- 11 Aug 2017
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Per Oral Immunotherapy Treatment in Severe IgE Mediated Milk, Peanut and Egg Allergy in Adults
- ClinicalTrials.gov ID
- NCT03361072
- Acronym / sponsor ID
- HUS/486/2017
- Conditions
- Food Allergy
- Keywords
- oral immunotherapy, milk, peanut, egg, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 11 Mar 2023 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to analyse the results of per oral immunotherapy treatment in severe milk, peanut or egg allergy in adults. This is the second part of the oral immunotherapy study in adults at Skin and Allergy Hospital. The diagnosis of food allergy is verified with positive history, skin prick tests, egg and milk allergen specific IgE (immunoglobulin E) antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. OIT (oral immunotherapy) is performed according to a detailed plan. Lung function parameters are followed before OIT and and a year after OIT.
Detailed description
30 patients with milk allergy (at least 18 year olds), 30 patients with peanut allergy and 30 patients with egg allergy are treated with OIT. The diagnosis of food allergy is verified with positive history, skin prick test, egg and milk allergen specific IgE antibodies. In addition, food allergy is verified with an open label (milk allergy) or blind (peanut and egg allergy) allergen specific challenge test. Quality of life, anxiety and patient history data is collected by questionnaires. All the patients undergo a spirometry with a bronchodilatator test, exhaled nitric oxide test and a methacholine challenge before and a year after oral immunotherapy. All the patients undergoing oral immunotherapy are prescribed with emergency medication such as antihistamine tablets, prednisolon tablets (40mg for three days in adults), epinephrine autoinjector (300 µg per dose) and salbutamol or terbutaline inhalator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective open label study on oral immunotherapy with either milk, or peanut or egg white food products.
| Arm | Type | Receives |
|---|---|---|
| Milk allergy | Experimental | Dietary Supplement: Oral immunotherapyMilk oral immunotherapy intervention for milk allergy |
| Peanut allergy | Experimental | Dietary Supplement: Oral immunotherapyPeanut oral immunotherapy intervention for peanut allergy |
| Egg allergy | Experimental | Dietary Supplement: Oral immunotherapyEgg oral immunotherapy intervention for egg allergy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe milk, peanut or egg allergy verified with positive symptom history, skin prick tests and serum IgE tests and a challenge test
Key exclusion criteria (2 listed)
- instable cerebrovascular or heart disease, active autoimmune disease or cancer, or current use of betablockers.
- poorly controlled asthma or FEV1 < 70% (FEV1< -2SD)
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 |
|---|---|---|
| Oral immunotherapyMilk, peanut or egg oral immunotherapy | Dietary supplement | Egg allergy, Milk allergy, Peanut allergy |
Primary outcome
Desensitisation
Time frame: 1 year, through study completion
Increase in tolerated dose (that is no symptoms if accidental exposure) of food compared to the pre-OIT, number of participants
1 secondary outcome
Worries Associated With Food Allergy
Time frame: 1 year, through study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Food Allergy
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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.
Paula Kauppi, MD, PhD principal investigator
Helsinki University Central 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 Oral immunotherapy in people with Food Allergy, 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 1 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 9 May 2025. 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?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Desensitisation (time frame: 1 year, through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2025.