Oral Immunotherapy in Young Children With Food Allergy

NCT05738798 | Enrolling By Invitation DMC

• 1 other identifier: NL81774.075.22
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Food Allergy

Keywords

Oral immunotherapy; infants; food allergy

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  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)

  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

  during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks

• Levels of allergy-related immune parameters

  at start of the therapy and after 6 and 12 months maintenance therapy

• adherence

  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)

  during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks)

Study Arms (2)

oral immunotherapy

EXPERIMENTAL

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

Dietary Supplement: oral immunotherapy

routine care

NO INTERVENTION

strictly avoidance of the specific allergenic food

Interventions

oral immunotherapy DIETARY_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.

oral immunotherapy

Eligibility Criteria

• Age: 9 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Deventer Ziekenhuis: lead
• Dutch National Health Care Institute: collaborator
• University of Twente: collaborator
• Utrecht University: collaborator

Study Sites (4)

Deventer hospital

Deventer, Overijssel, 7416SE, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Martini hospital

Groningen, Netherlands

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Ted Klok, MD PhD

  Deventer Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized open trial (no placebo involved)

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 22, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 01-07-2025 - 01-07-2026
• Access Criteria: Researchers wanting to use the data would have to contact the PIs with a research proposal and Statistical Analysis Plan (SAP).

Locations

NL (4)