An interventional study of assigned period of specific dietary restrictions in Egg Hypersensitivity, sponsored by Dominque Bullens. Active, not recruiting at 4 sites in Belgium. Open to participants aged 12 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Dominque Bullens · Not applicable, Interventional, and Other
The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product with regard to full egg tolerance induction.
The investigators want to test the hypothesis that a total period of 12 months of stepwise open egg introduction is not inferior when compared to a total period of 20 months gradual open egg introduction of a certain egg product (see steps for the specific egg products) with regard to full egg tolerance induction.
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 10 minutes 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 omelet, pancake 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 4 minutes 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 with the length of the previous step. 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.
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's planned enrollment of 62 is below the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →Dominque Bullens is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Very short arm (12 months): 3 months between every step. Step by step gradual introduction of egg containing food products during 12 months, unless next step can not be taken.
Behavioral: assigned period of specific dietary restrictions
Short arm (20 months): 5 months between every step. Step by step gradual introduction of egg containing food products during 20 months, unless next step can not be taken.
Behavioral: assigned period of specific dietary restrictions
Step by step gradual introduction of egg containing food products
Time to complete egg tolerance
The proportion of children in each group evolving from step 1 to step 5 within the anticipated time period (12 versus 20 months), followed by 3 versus 5 months of uneventful liberal egg intake for observation after step 5.
Time frame: 12 to 20 months
The proportion of children evolving from any step to the next step within anticipated time period
The proportion of children evolving from any step to the next step within anticipated time period
Time frame: 3 to 5 months
Influence of age at inclusion in relation to the proportion of failures
Influence of age at inclusion in relation to the proportion of failures
Time frame: 12 to 20 months
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures
Time frame: 12 to 20 months
Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures
Influence of the dietary intake of the specific egg-containing products (in number of times a week and in portion) in relation to the proportion of failures
Time frame: 12 to 20 months
Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.
We will study the difference in ICOS-expression as well as IL-10/IL-5 \& IL-10/IL-4 ratio at enrollment between healthy and egg-allergic children
Time frame: 12 to 20 months
Can in vitro BAT for a certain step predict tolerance?
Do the results of the BAT with different heated hen's egg ingredients correlate with the egg intake at home?
Time frame: 12 to 20 months
Plan to share: No — Data will be analysed and grouped before release
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Jul 2025, 54 months.
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Dominque Bullens