Clinical trial NCT05738798: Oral Immunotherapy in Young Children With Food Allergy
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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Food Allergy
Keywords: Oral immunotherapy
infants
food allergy
Lead sponsor: Deventer Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Dutch National Health Care Institute
name: University of Twente
name: Utrecht University
First posted: 2023-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open trial (no placebo involved)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT)
timeFrame: Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)
measure: Percentage of tolerant participants at week 78
timeFrame: week 78 = 6 months after stop of the 1-year oral immunotherapy
measure: Cost-effectiveness ratio at 18 months (week 78).
timeFrame: 18 months (week 78).
measure: Cost-utility ratio at 18 months (week 78).
timeFrame: 18 months (week 78): at the end of the study period.
Secondary outcomes:
measure: Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)
timeFrame: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
measure: Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation
timeFrame: during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks
measure: Levels of allergy-related immune parameters
timeFrame: at start of the therapy and after 6 and 12 months maintenance therapy
measure: adherence
timeFrame: during 1 year oral immunotherapy
measure: Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)
timeFrame: during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)
Other outcomes:
Locations:
city: Deventer
country: Netherlands
facility: Deventer hospital
state: Overijssel
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Groningen
country: Netherlands
facility: Martini hospital
Study officials:
affiliation: Deventer Ziekenhuis
name: Ted Klok, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: