NCT02487420

Brief Summary

  1. 1.The investigators here want to test the hypothesis that a total period of 18 months of gradual open introduction of a certain egg product with regard to full egg tolerance induction is not inferior when compared to a total period of 30 months gradual open introduction of a certain egg product (see steps for the specific egg products) after tolerance for baked egg has been obtained.
  2. 2.The investigators also want to define step-specific 'tolerance-failures' and study the relevance of specific IgE to specific egg components to predict failures at each step.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

5.8 years

First QC Date

June 29, 2015

Last Update Submit

November 4, 2021

Conditions

Egg Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • time to complete egg tolerance

    raw egg tolerance (eg in chocolate mousse)

    18 to 30 months

Secondary Outcomes (1)

  • Measurement of specific IgE to egg white components to predict complete egg tolerance

    18 to 30 months

Study Arms (2)

Arm 18m

OTHER

arm 18m: 6 months between step 1 and step 2; 6 months between step 2 and step 3, 3 months between all other steps step by step gradual introduction of egg containing food products during 18 months, unless next step can not be taken

Behavioral: shorter or longer period of specific dietary restrictions

arm 30 m

OTHER

arm 30m: 9 months between step 1 and step 2; 9 months between step 2 and step 3, 6 months between all other steps step by step gradual introduction of egg containing food products during 30 months, unless next step can not be taken

Behavioral: shorter or longer period of specific dietary restrictions

Interventions

shorter or longer period of specific dietary restrictionsBEHAVIORAL

step by step gradual introduction of egg containing food products

Arm 18marm 30 m

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children (1-18y) had or have a clinical diagnosis of IgE mediated hen's egg allergy based on positive history as well as skin prick testing and/or specific IgE detection by CAPtest in an allergy clinic
  • Children are at least 12 months old before introduction of heated egg is considered
  • Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at presentation
  • Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake provocation test -

You may not qualify if:

  • Children had a moderate-to severe anaphylaxis due to egg ingestion
  • Children are younger than 12 months old at the moment of passing heated egg open provocation test
  • Parents are not able or not willing to test a certain step in the tolerance induction at home -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Imelda Hospital, Bonheiden

Bonheiden, Belgium

Location

Sint-Jan

Bruges, 8000, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Ghent, Belgium

Location

Jessa Hospital

Hasselt, Belgium

Location

Sint-Jan

Ostend, 8400, Belgium

Location

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dominique MA Bullens, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2021

Study Completion

April 1, 2022

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

data will be analysed and grouped before release

Locations

BE(6)