Food AllergyNCT01822353
The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
A study testing Dietary supplement in people with Food Allergy, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Nov 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- severe IgE-mediated milk allergy or
- severe IgE-mediated egg allergy or
- severe IgE-mediated nut allergy or
- 18-50 years
Who cannot join
- instable cerebrovascular or heart disease
- active autoimmune disease or cancer
- use of betablocker agents
- poorly controlled asthma
- FEV1 < 70% of the predicted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk and Nut Allergy in Adults
In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.
The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults.
Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?
Read the detailed description
Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:
- 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.
- 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk hyposensitisation treatment.
The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg, milk and nut allergen specific IgE antibodies. In addition, food allergy is verified with an allergen specific challenge test.
Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and other asthma medication is allowed. Atopic subjects may have additional skin symptoms. Quality of life, anxiety and patient history data is collected by questionnaires. All patients undergo a spirometry with a bronchodilatation test, fractional exhaled nitric oxide and a methacholine challenge before and a year after oral immunotherapy. Those with test results diagnostic for asthma are treated with asthma medication before hyposensitisation treatment is started.
Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or FEV1 < 70% are not tolerated.
In oral immunotherapy, increasing doses are given first observed, and then daily at home. If the subject does not tolerate a given dose and symptoms are mild, then that dose or the previously tolerated one is repeated, and the protocol proceeds as outlined. If the subject experiences significant symptoms, then the protocol is stopped, and the highest tolerated dose is used as the starting daily one.
- Conditions
- Food Allergy
- Being tested
- Dietary supplement
- Keywords
- food allergy, milk allergy, egg allergy, nut allergy
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
Also called Milk, Egg protein, Nut cream
Milk, egg or nut oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Milk allergy | Experimental | Dietary supplement, milk in increasing dosages, delivered daily and orally. Receives: Dietary Supplement: Dietary supplement |
| Egg allergy | Experimental | Dietary supplement, egg protein given in increasing dosages, delivered daily and orally. Receives: Dietary Supplement: Dietary supplement |
| Nut allergy | Experimental | Dietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally. Receives: Dietary Supplement: Dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy
Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
Measured: One year
Secondary outcomes (3)
Effect of Therapy on Lung Function.
Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?
Measured: One year
Does Oral Immunotherapy Change Bronchial Hyperreactivity?
Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?
Measured: One year
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?
Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2017
- Study completionNov 2017
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
- Masking
- None (open label)
- Enrolment
- 23 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
- Mika J Mäkelä, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822353
- Sponsor's protocol ID
- HUS21813030112
- Status last verified
- Jan 2021
- First submitted
- 7 Mar 2013
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk and Nut Allergy in Adults
- ClinicalTrials.gov ID
- NCT01822353
- Acronym / sponsor ID
- HUS21813030112
- Conditions
- Food Allergy
- Keywords
- food allergy, milk allergy, egg allergy, nut allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 9 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE.
The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults.
Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?
Detailed description
Up to 100 subjects are studied. All subjects are adults having no other severe chronic diseases. The subjects belong to four different groups:
- 30 18-50 year olds who start per oral immunotherapy treatment in severe egg allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe milk allergy.
- 30 18-50 year olds who start per oral immunotherapy treatment in severe nut allergy.
- 10 milk allergic 18-50 year olds that have been treated as pilot patients with milk hyposensitisation treatment.
The diagnosis of milk or egg allergy is verified with positive history, skin prick test, egg, milk and nut allergen specific IgE antibodies. In addition, food allergy is verified with an allergen specific challenge test.
Atopic subjects may have simultaneously other allergies. Intermittent mild asthma, and mild and moderate persistent asthma are tolerated and treatment with inhaled steroids and other asthma medication is allowed. Atopic subjects may have additional skin symptoms. Quality of life, anxiety and patient history data is collected by questionnaires. All patients undergo a spirometry with a bronchodilatation test, fractional exhaled nitric oxide and a methacholine challenge before and a year after oral immunotherapy. Those with test results diagnostic for asthma are treated with asthma medication before hyposensitisation treatment is started.
Exclusion criteria: adults with instable cerebrovascular or heart disease, active autoimmune disease or cancer, or use of betablocker agents. In addition, poorly controlled asthma or FEV1 < 70% are not tolerated.
In oral immunotherapy, increasing doses are given first observed, and then daily at home. If the subject does not tolerate a given dose and symptoms are mild, then that dose or the previously tolerated one is repeated, and the protocol proceeds as outlined. If the subject experiences significant symptoms, then the protocol is stopped, and the highest tolerated dose is used as the starting daily one.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk allergy | Experimental | Dietary Supplement: Dietary supplementDietary supplement, milk in increasing dosages, delivered daily and orally. |
| Egg allergy | Experimental | Dietary Supplement: Dietary supplementDietary supplement, egg protein given in increasing dosages, delivered daily and orally. |
| Nut allergy | Experimental | Dietary Supplement: Dietary supplementDietary supplement, nut cream including nut allergens, delivered in increasing dosages, daily and orally. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- severe IgE-mediated milk allergy or
- severe IgE-mediated egg allergy or
- severe IgE-mediated nut allergy or
- 18-50 years
Key exclusion criteria (5 listed)
- instable cerebrovascular or heart disease
- active autoimmune disease or cancer
- use of betablocker agents
- poorly controlled asthma
- FEV1 < 70% of the predicted
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 |
|---|---|---|
| Dietary supplementAlso: Milk, Egg protein, Nut creamMilk, egg or nut oral immunotherapy | Dietary supplement | Egg allergy, Milk allergy, Nut allergy |
Primary outcome
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy
Time frame: One year
Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.
3 secondary outcomes
Effect of Therapy on Lung Function.
Time frame: One year
Does Oral Immunotherapy Change Bronchial Hyperreactivity?
Time frame: One year
Does the Oral Immunotherapy Have en Effect on Airway Inflammation?
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
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 Dietary supplement 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 4 inclusion and 5 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 11 Feb 2021. 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 Aug 2019). 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?
Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy (time frame: One year). 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 11 Feb 2021.