Clinical Trial: Gradual Egg-tolerance Induction in Hen's Egg Allergic Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)

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 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 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 pre
Sponsor: Dominque Bullens

Current Primary Outcome: time to complete egg tolerance [ Time Frame: 18 to 30 months ]

raw egg tolerance (eg in chocolate mousse)


Original Primary Outcome: Same as current

Current Secondary Outcome: Measurement of specific IgE to egg white components to predict complete egg tolerance [ Time Frame: 18 to 30 months ]

Original Secondary Outcome: use of specific IgE to egg white components to predict complete egg tolerance [ Time Frame: 18 to 30 months ]

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: June 29, 2015
Date Started: July 2015
Date Completion: December 2018
Last Updated: June 9, 2016
Last Verified: June 2016