Gradual Egg-tolerance Induction in Hen's Egg Allergic Children (TETI)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Egg Hypersensitivity
• Intervention / Treatment: Behavioral: shorter or longer period of specific dietary restrictions

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Imelda Hospital, Bonheiden
  • Brugge, Belgium, 8000
    • Sint-Jan
  • Ghent, Belgium
    • Algemeen Ziekenhuis Maria Middelares
  • Hasselt, Belgium
    • Jessa hospital
  • Oostende, Belgium, 8400
    • Sint-Jan
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospital of Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 18m; arm 18m: 6 months between step 1 and step 2; 6 months between step 2 and step 3, 3 months between all other steps step by step gradual introduction of egg containing food products during 18 months, unless next step can not be taken	Behavioral: shorter or longer period of specific dietary restrictions; step by step gradual introduction of egg containing food products
Other: arm 30 m; arm 30m: 9 months between step 1 and step 2; 9 months between step 2 and step 3, 6 months between all other steps step by step gradual introduction of egg containing food products during 30 months, unless next step can not be taken	Behavioral: shorter or longer period of specific dietary restrictions; step by step gradual introduction of egg containing food products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to complete egg tolerance	raw egg tolerance (eg in chocolate mousse)	18 to 30 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of specific IgE to egg white components to predict complete egg tolerance	18 to 30 months

Collaborators and Investigators

• Sponsor: Dominque Bullens
• Collaborators: Jessa Hospital; Imelda Hospital, Bonheiden; AZ Sint-Jan AV; Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Dominique MA Bullens, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): May 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Egg Hypersensitivity
• Other Study ID Numbers: S57588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data will be analysed and grouped before release