Gradual Egg-tolerance Induction in Hen's Egg Allergic Children

NCT ID: NCT02487420

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2022-04-30

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 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.

Conditions

Egg Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

shorter or longer period of specific dietary restrictions

Intervention Type: BEHAVIORAL

step by step gradual introduction of egg containing food products

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

Group Type: OTHER

shorter or longer period of specific dietary restrictions

Intervention Type: BEHAVIORAL

step by step gradual introduction of egg containing food products

Interventions

shorter or longer period of specific dietary restrictions

step by step gradual introduction of egg containing food products

Intervention Type: BEHAVIORAL

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 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 -

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: collaborator

Imelda Hospital, Bonheiden

OTHER

Sponsor Role: collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role: collaborator

Dominque Bullens

OTHER

Sponsor Role: lead

Responsible Party

Dominque Bullens

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique MA Bullens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

University Hospital of Leuven

Leuven, Vlaams-Brabant, Belgium

Imelda Hospital, Bonheiden

Bonheiden, , Belgium

Sint-Jan

Bruges, , Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, , Belgium

Jessa Hospital

Hasselt, , Belgium

Sint-Jan

Ostend, , Belgium

Countries

Belgium

Other Identifiers

S57588

Identifier Type: -

Identifier Source: org_study_id