NCT05740163

Brief Summary

The aim of the study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white. Study hypothesis: With this method the risk for severe allergic reaction to egg protein is reduced and the diet can partly or completely be normalized.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Dec 2019Dec 2026

Study Start

First participant enrolled

December 30, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

January 16, 2023

Last Update Submit

April 9, 2024

Conditions

Egg Allergy

Keywords

Oral immunotherapyEgg allergyChildren

Outcome Measures

Primary Outcomes (1)

  • Efficacy of oral egg immunotherapy

    Total number of patients who achieved tolerance to egg protein during OIT (negative egg challenge) compared to the number of patients who received only partly tolerance or failed to develop any level of unresponsiveness.

    Within 12 months of study

Secondary Outcomes (19)

  • Safety of oral egg immunotherapy

    Within 12 months of study

  • Specification of adverse reactions during egg OIT in patients without asthma

    Within 12 months of study

  • Number and severity of anaphylactic reactions during OIT without asthma

    Within 12 months of study

  • Specification of adverse reactions during OIT in patients with asthma

    Within 12 months of study

  • Number and severity of anaphylactic reactions durin OIT in patients with asthma

    Within 12 months of study

  • +14 more secondary outcomes

Study Arms (4)

Egg allergy with asthma with intervention

EXPERIMENTAL

Immunotherapy Egg product including egg white and yolk allergens

Dietary Supplement: Egg product including egg white and yolk allergens

Egg allergy without asthma with intervention

EXPERIMENTAL

Immunotherapy Egg product including egg white and yolk allergens

Dietary Supplement: Egg product including egg white and yolk allergens

Egg allergy with asthma without intervention

NO INTERVENTION

No intervention, control

Egg allergy without asthma without intervention

NO INTERVENTION

No intervention, control

Interventions

Egg product including egg white and yolk allergensDIETARY_SUPPLEMENT

Egg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.

Egg allergy with asthma with interventionEgg allergy without asthma with intervention

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to 16 years
  • Elevated spesific serum IgE to egg (\> 5 kU/l) and/or positive skin prick to egg allergen
  • Positive oral food challenge for egg or anaphylaxis reaction to egg within the 6 months
  • Diet free from egg in any form

You may not qualify if:

  • Age less than 6 years or more than 16 years
  • Poor asthma control or uncontrolled asthma
  • Severe/significant cardiovascular disease
  • Autoimmune disease
  • Malignancy
  • Medication: beta bloker, angiotensin-converting-enzyme inhibitors (ACE inhibitors), Monoamine oxidase inhibitors (MAOIs)
  • Poor compliance
  • Fear of immunotherapy
  • Desensitization to alfa-gal-protein (mammalian meat allergy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oulu University Hospital

Oulu, 90230, Finland

RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

RECRUITING

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Rüdiger Schultz, MD., PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rüdiger Schultz, MD., PhD

CONTACT

+358rudiger.schultz58@gmail.com

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
Specialist in Pediatric Allergology

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 22, 2023

Study Start

December 30, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)