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

Launched by DOMINQUE BULLENS · Dec 18, 2020

Keywords

ClinConnect Summary

The TETI-II Study is a clinical trial designed to help children with hen's egg allergies learn to tolerate eggs over time. Researchers want to find out if gradually introducing eggs into their diet over 12 months is as effective as a longer 20-month approach in helping these children develop a full tolerance to eggs. This is important because many children struggle with egg allergies, and finding ways to safely include eggs in their diet can improve their quality of life.

To be eligible for this study, children aged between 1 and 18 years must have a confirmed allergy to eggs, shown through allergy testing. They should also have a good chance of tolerating baked eggs, which means they have had positive results in specific tests. It's important that the children have not experienced severe allergic reactions, known as grade 4 anaphylaxis, when eating eggs. Parents should be willing to follow a specific diet that includes eggs and agree to participate in the study. Throughout the trial, participants can expect to follow a carefully monitored plan to introduce eggs into their diets step by step.

Gender

ALL

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 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).
• • 4. 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:
• • 1. 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
• • 2. Children are younger than 12 months old at the moment of passing cake open provocation test
• • 3. Parents are not able or not willing to adhere to a certain egg step-containing diet on a regular basis at home
• • 4. Parents and/or children are not willing to give IC/assent