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Status unknownNCT02487420TETIUpdated Nov 5, 2021

Gradual Egg-tolerance Induction in Hen's Egg Allergic Children

An interventional study of shorter or longer period of specific dietary restrictions in Egg Hypersensitivity, sponsored by Dominque Bullens. Status unknown at 6 sites in Belgium. Open to participants aged 12 Months to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-05.

Sponsored by Dominque Bullens · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
12 Months to 18 Years
Sex
All
01

Study summary

  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. 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.
Read the detailed description
  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 to baked egg has been obtained.
  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.

Step 1: open baked egg test passed (either at home or in the hospital): this is routine clinical practice; afterwards daily intake of increasing amounts of heated egg (amounts to be noted in diary)

Step 2: open provocation test at home with hard-boiled egg, both hen's egg white and yolk, passed; afterwards weekly intake of either hard-boiled egg white or yolk or both (amounts and days to be noted in diary)

Step 3: open provocation test at home with waffles, omelet, pan cake or scrambled egg passed; afterwards weekly or two-weekly intake of one of these specific preparation forms or of the previous preparation forms (amounts, days and preparation to be noted in diary)

Step 4: open provocation test at home with fried or poached egg or softly boiled egg with liquid yolk; afterwards regular intake of one of these preparation forms or one of the prior steps (amounts, days and preparation to be noted in diary)

Step 5: open provocation test at home with raw egg: eg. In chocolate mousse; mayonnaise or tiramisu; afterwards unlimited intake of all egg containing preparation forms (for 3 months in both groups to be noted in the diary)

If tolerance to a certain step is not yet present (this is: if any reaction occurred during the months registered between two steps), the next step will be postponed. The number of failures (any reaction in relation to egg ingestion), the type of reaction and the additional time period necessary before the next step can be taken, will be recorded. After each time period, the investigators will measure specific IgE to hen's egg white and to Gal d 1, as standard clinical practice.

02

Conditions studied

  • Egg Hypersensitivity

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03

In context

Egg Hypersensitivity

38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.

This study's enrollment of 86 is above the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.

Browse Egg Hypersensitivity studies →

Lead sponsor

Dominque Bullens is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Children are at least 12 months old before introduction of heated egg is considered
  3. Children did not suffer from a moderate-to-severe anaphylaxis due to egg-ingestion at presentation
  4. Children have specific IgE levels to Gal d 1 below 1.2 kU/mL or passed cake provocation test -

Exclusion criteria

Exclusion Criteria:

  1. Children had a moderate-to severe anaphylaxis due to egg ingestion
  2. Children are younger than 12 months old at the moment of passing heated egg open provocation test
  3. Parents are not able or not willing to test a certain step in the tolerance induction at home -
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Other
    Arm 18m

    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

  • Other
    arm 30 m

    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

  • Behavioralshorter or longer period of specific dietary restrictions

    step by step gradual introduction of egg containing food products

06

What researchers measure

Primary outcomes

  1. time to complete egg tolerance

    raw egg tolerance (eg in chocolate mousse)

    Time frame: 18 to 30 months

Secondary outcomes

  1. Measurement of specific IgE to egg white components to predict complete egg tolerance

    Time frame: 18 to 30 months

07

Study locations

6 sites
  • University Hospital of Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
  • Imelda Hospital, Bonheiden
    Bonheiden, Belgium
  • Sint-Jan
    Brugge, 8000, Belgium
  • Algemeen Ziekenhuis Maria Middelares
    Ghent, Belgium
  • Jessa Hospital
    Hasselt, Belgium
  • Sint-Jan
    Oostende, 8400, Belgium
08

References and documents

Individual participant data

Plan to share: No — data will be analysed and grouped before release

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02487420
Lead sponsor
Dominque Bullens
Collaborators
Jessa Hospital, Algemeen Ziekenhuis Maria Middelares, Imelda Hospital, Bonheiden, AZ Sint-Jan AV
Responsible party
Dominque Bullens (MD, PhD, Universitaire Ziekenhuizen KU Leuven) — Sponsor-investigator
First posted
Jul 1, 2015
Start date
Jul 1, 2015
Primary completion
May 2021
Completion
Apr 2022 (estimated)
Last update
Nov 5, 2021

Study contacts

Dominique MA Bullens, MD, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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