Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02487420 |
| Other study ID # |
S57588 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2015 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
November 2021 |
| Source |
Universitaire Ziekenhuizen Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
