Clinical trial NCT02487420: Gradual Egg-tolerance Induction in Hen's Egg Allergic Children
Official title: Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Egg Hypersensitivity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Algemeen Ziekenhuis Maria Middelares
name: Imelda Hospital, Bonheiden
name: AZ Sint-Jan AV
First posted: 2015-07-01
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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:

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 -

Primary outcomes:
measure: time to complete egg tolerance
timeFrame: 18 to 30 months
Secondary outcomes:
measure: Measurement of specific IgE to egg white components to predict complete egg tolerance
timeFrame: 18 to 30 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
state: Vlaams-Brabant
city: Bonheiden
country: Belgium
facility: Imelda Hospital, Bonheiden
city: Brugge
country: Belgium
facility: Sint-Jan
city: Ghent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Oostende
country: Belgium
facility: Sint-Jan
Study officials:
affiliation: UZ Leuven
name: Dominique MA Bullens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: