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Oral Immunotherapy in Young Children With Food Allergy (ORKA-NL)

Primary Purpose

Food Allergy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
oral immunotherapy
Sponsored by
Deventer Ziekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Oral immunotherapy, infants, food allergy

Eligibility Criteria

9 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: (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.

Sites / Locations

  • Deventer hospital
  • Amsterdam UMC, location AMC
  • Reinier de Graaf Gasthuis
  • Martini hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

oral immunotherapy

routine care

Arm Description

oral immunotherapy, maintenance phase with daily 300 mg allergenic protein during 1 year

strictly avoidance of the specific allergenic food

Outcomes

Primary Outcome Measures

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).
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).
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.
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.

Secondary Outcome Measures

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)
Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation
(Serious) adverse events related to oral immunotherapy
Levels of allergy-related immune parameters
Levels of allergen specific IgE and IgG4
adherence
Rate of daily providing the 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)

Full Information

First Posted
December 20, 2022
Last Updated
February 11, 2023
Sponsor
Deventer Ziekenhuis
Collaborators
Dutch National Health Care Institute, University of Twente, Utrecht University
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1. Study Identification

Unique Protocol Identification Number
NCT05738798
Brief Title
Oral Immunotherapy in Young Children With Food Allergy
Acronym
ORKA-NL
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deventer Ziekenhuis
Collaborators
Dutch National Health Care Institute, University of Twente, Utrecht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Oral immunotherapy, infants, food allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized open trial (no placebo involved)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral immunotherapy
Arm Type
Experimental
Arm Description
oral immunotherapy, maintenance phase with daily 300 mg allergenic protein during 1 year
Arm Title
routine care
Arm Type
No Intervention
Arm Description
strictly avoidance of the specific allergenic food
Intervention Type
Dietary Supplement
Intervention Name(s)
oral immunotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT)
Description
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).
Time Frame
Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)
Title
Percentage of tolerant participants at week 78
Description
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).
Time Frame
week 78 = 6 months after stop of the 1-year oral immunotherapy
Title
Cost-effectiveness ratio at 18 months (week 78).
Description
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.
Time Frame
18 months (week 78).
Title
Cost-utility ratio at 18 months (week 78).
Description
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.
Time Frame
18 months (week 78): at the end of the study period.
Secondary Outcome Measure Information:
Title
Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)
Description
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)
Time Frame
during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Title
Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation
Description
(Serious) adverse events related to oral immunotherapy
Time Frame
during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks
Title
Levels of allergy-related immune parameters
Description
Levels of allergen specific IgE and IgG4
Time Frame
at start of the therapy and after 6 and 12 months maintenance therapy
Title
adherence
Description
Rate of daily providing the oral immunotherapy
Time Frame
during 1 year oral immunotherapy
Title
Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)
Description
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)
Time Frame
during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Klok, MD PhD
Organizational Affiliation
Deventer Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deventer hospital
City
Deventer
State/Province
Overijssel
ZIP/Postal Code
7416SE
Country
Netherlands
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
Martini hospital
City
Groningen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
01-07-2025 - 01-07-2026
IPD Sharing Access Criteria
Researchers wanting to use the data would have to contact the PIs with a research proposal and Statistical Analysis Plan (SAP).

Learn more about this trial

Oral Immunotherapy in Young Children With Food Allergy

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