Food AllergyORKA-NLNCT05738798
Oral Immunotherapy in Young Children With Food Allergy
A study testing oral immunotherapy in people with Food Allergy, run by Deventer Ziekenhuis at 4 sites in Netherlands.
Trial summary
The goal of this clinical trial is to learn about oral immunotherapy in food allergic children < 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Read more about this study
- Who is it for?
- Ages 9 to 30 months
- 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
- 500 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Feb 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sIgE > 0.35kU/l) and a positive oral food challenge.
- The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s).
Who cannot join
- (Suspected) eosinophilic oesophagitis
- Uncontrolled asthma/ viral wheeze.
- The inability of parents to follow instructions, recognize allergic reactions or administer emergency medication.
- Participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites
Amsterdam UMC, location AMC
Amsterdam
Reinier de Graaf Gasthuis
Delft
Deventer hospital
Deventer, Overijssel, 7416SE
Martini hospital
Groningen
About this study
Official title: A Randomized Controlled Trial to Investigate the (Cost)Effectiveness of Oral Immunotherapy With Different Allergens in Young Children With an Established Food Allergy
The goal of this clinical trial is to learn about oral immunotherapy in food allergic children < 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.
Read the detailed description
Primary objective: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? Secondary objective: What is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? Study design: randomized controlled superiority trial Study population: Children between 9 and 30 months old with an IgE-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. Intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group.
Main study parameters/endpoints: Long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.
- Conditions
- Food Allergy
- Being tested
- oral immunotherapy
- Keywords
- Oral immunotherapy, infants, food allergy
- 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
oral immunotherapy is performed by freely available, widely used food products, regularly part of a normal infant's diet such as peanut butter or boiled egg.
| Study group | Role | What they receive |
|---|---|---|
| oral immunotherapy | Experimental | oral immunotherapy, maintenance phase with daily 300 mg allergenic protein during 1 year Receives: Dietary Supplement: oral immunotherapy |
| routine care | No intervention | strictly avoidance of the specific allergenic food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT)
Definition of sustained unresponsiveness: a participant who passed an oral food challenge (OFC) to 4.2 gram of the allergenic protein.
Definition of the allergenic protein: the allergenic protein which induced an allergic response at an OFC at the start of the study, and was administered to the patient during the OIT (i.e. milk, egg, peanut, hazelnut, cashew or walnut).
Measured: Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)
Percentage of tolerant participants at week 78
In children achieving sustained unresponsiveness (outcome 1), the allergen is introduced into the diet by parents at a regular base. Six months after discontinuation of the OIT, tolerance to the specific allergenic protein is assessed.
Definition of tolerant: Percentage of children with uncomplicated (i.e. without any allergic symptoms) consumption at home of a full dose of the specific allergenic protein (e.g. a glass of milk or a sandwich with peanut butter).
Measured: week 78 = 6 months after stop of the 1-year oral immunotherapy
Cost-effectiveness ratio at 18 months (week 78).
Incremental cost-effectiveness ratio (ICER) at 18 months (week 78). Costs associated with oral immunotherapy will be measured in Euros. Effectiveness will be considered as percentage of tolerant participants at week 78.
Measured: 18 months (week 78).
Cost-utility ratio at 18 months (week 78).
Incremental cost-utility ratio (ICUR) will be calculated for both groups using health-related quality of life (HRQoL) scores from the AQoL-6D (assessment of quality of life - 6 dimensions) and converted to utility scores and will be expressed in euros per QALY.
Measured: 18 months (week 78): at the end of the study period.
Secondary outcomes (5)
Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)
Children's quality of life as measured by:
- Food Allergy Quality of Life Questionnaire - parental form (FAQLQ-PF) This questionnaire consists of 14 questions to be answered on a 7-point Likert-scale. Minimum score is 0 points (no impact of food allergy on quality of life), maximum score is 84 (high impact of food allergy on quality of life)
Measured: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation
(Serious) adverse events related to oral immunotherapy
Measured: during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks
Levels of allergy-related immune parameters
Levels of allergen specific IgE and IgG4
Measured: at start of the therapy and after 6 and 12 months maintenance therapy
adherence
Rate of daily providing the oral immunotherapy
Measured: during 1 year oral immunotherapy
Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)
Parental quality of life as measured by:
- Food Allergy Quality of Life- Parental Burden (FAQL-PB) This questionnaire consists of 17 questions to be answered on a 7-point Likert-scale. Minimum score is 0 points (no parental burden), maximum score is 102 (severe parental burden)
Measured: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open trial (no placebo involved)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deventer Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch National Health Care Institute, University of Twente, Utrecht University
- Responsible party
- Principal investigator, Ted Klok, Deventer Ziekenhuis
- Investigators
- Ted Klok, MD PhD, Principal investigator, Deventer Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738798
- Sponsor's protocol ID
- NL81774.075.22
- Acronym
- ORKA-NL
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be stored in SPSS and Excel and analyzed in SPSS. Access to trial IPD can be requested after the study is completed by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact wetenschapsbureau@dz.nl
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Investigate the (Cost)Effectiveness of Oral Immunotherapy With Different Allergens in Young Children With an Established Food Allergy
- ClinicalTrials.gov ID
- NCT05738798
- Acronym / sponsor ID
- ORKA-NL / NL81774.075.22
- Conditions
- Food Allergy
- Keywords
- Oral immunotherapy, infants, food allergy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Deventer ZiekenhuisUniversity, hospital or other
- Collaborators
- Dutch National Health Care Institute, University of Twente, Utrecht University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- 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 goal of this clinical trial is to learn about oral immunotherapy in food allergic children < 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.
Detailed description
Primary objective: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? Secondary objective: What is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? Study design: randomized controlled superiority trial Study population: Children between 9 and 30 months old with an IgE-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. Intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group.
Main study parameters/endpoints: Long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open trial (no placebo involved)
| Arm | Type | Receives |
|---|---|---|
| oral immunotherapy | Experimental | Dietary Supplement: oral immunotherapyoral immunotherapy, maintenance phase with daily 300 mg allergenic protein during 1 year |
| routine care | No intervention | –strictly avoidance of the specific allergenic food |
Who may qualify
- Ages
- 9 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sIgE > 0.35kU/l) and a positive oral food challenge.
- The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s).
Key exclusion criteria (4 listed)
- (Suspected) eosinophilic oesophagitis
- Uncontrolled asthma/ viral wheeze.
- The inability of parents to follow instructions, recognize allergic reactions or administer emergency medication.
- Participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.
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 immunotherapyoral immunotherapy is performed by freely available, widely used food products, regularly part of a normal infant's diet such as peanut butter or boiled egg. | Dietary supplement | oral immunotherapy |
Primary outcome
Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT)
Time frame: Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)
Definition of sustained unresponsiveness: a participant who passed an oral food challenge (OFC) to 4.2 gram of the allergenic protein. Definition of the allergenic protein: the allergenic protein which induced an allergic response at an OFC at the start of the study, and was administered to the patient during the OIT (i.e. milk, egg, peanut, hazelnut, cashew or walnut).
Percentage of tolerant participants at week 78
Time frame: week 78 = 6 months after stop of the 1-year oral immunotherapy
In children achieving sustained unresponsiveness (outcome 1), the allergen is introduced into the diet by parents at a regular base. Six months after discontinuation of the OIT, tolerance to the specific allergenic protein is assessed. Definition of tolerant: Percentage of children with uncomplicated (i.e. without any allergic symptoms) consumption at home of a full dose of the specific allergenic protein (e.g. a glass of milk or a sandwich with peanut butter).
Cost-effectiveness ratio at 18 months (week 78).
Time frame: 18 months (week 78).
Incremental cost-effectiveness ratio (ICER) at 18 months (week 78). Costs associated with oral immunotherapy will be measured in Euros. Effectiveness will be considered as percentage of tolerant participants at week 78.
Cost-utility ratio at 18 months (week 78).
Time frame: 18 months (week 78): at the end of the study period.
Incremental cost-utility ratio (ICUR) will be calculated for both groups using health-related quality of life (HRQoL) scores from the AQoL-6D (assessment of quality of life - 6 dimensions) and converted to utility scores and will be expressed in euros per QALY.
5 secondary outcomes
Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)
Time frame: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation
Time frame: during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks
Levels of allergy-related immune parameters
Time frame: at start of the therapy and after 6 and 12 months maintenance therapy
adherence
Time frame: during 1 year oral immunotherapy
Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)
Time frame: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. Data collected for this study will be stored in SPSS and Excel and analyzed in SPSS. Access to trial IPD can be requested after the study is completed by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact wetenschapsbureau@dz.nl
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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.
Ted Klok, MD PhD principal investigator
Deventer Ziekenhuis
4 sites 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 Deventer Ziekenhuis at 4 sites in Netherlands.
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 4 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: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT) (time frame: Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)). The study lists 4 primary outcomes in all. 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 16 Sep 2025.