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

NCT04677790 | Active Not Recruiting

• 1 other identifier: S64538
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

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 introduction of a certain egg product with regard to full egg tolerance induction.

Conditions

Egg Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Time to complete egg tolerance

  The proportion of children in each group evolving from step 1 to step 5 within the anticipated time period (12 versus 20 months), followed by 3 versus 5 months of uneventful liberal egg intake for observation after step 5.

  12 to 20 months

Secondary Outcomes (6)

• The proportion of children evolving from any step to the next step within anticipated time period

  3 to 5 months

• Influence of age at inclusion in relation to the proportion of failures

  12 to 20 months

• Influence of specific IgE of hen's egg and/or components in relation to the proportion of failures

  12 to 20 months

• Influence of the dietary intake of the specific egg-containing products in relation to the proportion of failures

  12 to 20 months

• Induction of Treg over time in parallel to gradual complete hen's egg tolerance induction.

  12 to 20 months

Study Arms (2)

"Very short arm" (12 months)

ACTIVE COMPARATOR

Very short arm (12 months): 3 months between every step. Step by step gradual introduction of egg containing food products during 12 months, unless next step can not be taken.

Behavioral: assigned period of specific dietary restrictions

"Short arm" (20 months)

ACTIVE COMPARATOR

Short arm (20 months): 5 months between every step. Step by step gradual introduction of egg containing food products during 20 months, unless next step can not be taken.

Behavioral: assigned period of specific dietary restrictions

Interventions

assigned period of specific dietary restrictions BEHAVIORAL

Step by step gradual introduction of egg containing food products

"Short arm" (20 months); "Very short arm" (12 months)

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: collaborator
• Dominque Bullens: lead
• Imelda Hospital, Bonheiden: collaborator

Study Sites (4)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Imelda Hospital Bonheiden

Bonheiden, Belgium

Location

Sint-Jan

Bruges, Belgium

Location

AZ maria middelares

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dominique Bullens, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: After obtaining informed consent from the parents and oral or written assent from the children (where appropriate) we will randomize the children 1:1 in two groups, anticipated to be 12 and 20 months. Randomization by dice: even: very-short arm (12 months), uneven: short arm (20 months).

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 9, 2020
• Primary Completion: July 2, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)