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Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)

Belgium62 participantsStarted 2020-12-09

Plain-language summary

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.

Who can participate

Age range12 Months – 18 Years

SexALL

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Inclusion criteria

✓. 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 grade 4 anaphylaxis due to egg-ingestion at presentation (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25).
✓. Children have specific IgE levels to Gal d 1 below 1.2 kU/mL (12-24 months) or below 5 kU/mL (\>24 months) or have a level that predicts a good chance (\>75%) to pass the baked egg provocation test by cake (see Bartnikas LM et al, J Allergy Clin Immunol Pract 2013; 1: 354-360) and/or children passed baked egg provocation test by cake executed on clinical judgement.

Exclusion criteria

✕. Children had grade 4 anaphylaxis (for grade 4 anaphylaxis, see EAACI anaphylaxis guidelines, Muraro A et al, Allergy. 2014 Aug;69(8):1008-25) due to egg ingestion
✕. Children are younger than 12 months old at the moment of passing cake open provocation test
✕. Parents are not able or not willing to adhere to a certain egg step-containing diet on a regular basis at home
✕. Parents and/or children are not willing to give IC/assent

What they're measuring

Time to complete egg tolerance

Timeframe: 12 to 20 months

Trial details

NCT IDNCT04677790

SponsorDominque Bullens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-02

View on ClinicalTrials.gov More Egg Hypersensitivity trials