Status:
UNKNOWN
Gradual Egg-tolerance Induction in Hen's Egg Allergic Children Who Tolerate Baked Egg (TETI-II Study)
Lead Sponsor:
Dominque Bullens
Collaborating Sponsors:
Imelda Hospital, Bonheiden
AZ Sint-Jan AV
Conditions:
Egg Hypersensitivity
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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 introduct...
Detailed Description
1. 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 introd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04677790
Start Date
December 9 2020
End Date
December 1 2024
Last Update
October 17 2023
Active Locations (4)
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1
University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
2
Imelda Hospital Bonheiden
Bonheiden, Belgium
3
Sint-Jan
Bruges, Belgium
4
AZ maria middelares
Ghent, Belgium, 9000