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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Months - 18 Years
Gender All
More Inclusion & Exclusion 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 -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02487420
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dominque Bullens
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dominique MA Bullens, MD, PhD
Principal Investigator Affiliation UZ Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Egg Hypersensitivity
Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

Behavioral: - shorter or longer period of specific dietary restrictions

step by step gradual introduction of egg containing food products

Contact a Trial Team

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International Sites

University Hospital of Leuven, Leuven, Vlaams-Brabant, Belgium

Status

Address

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000

Imelda Hospital, Bonheiden, Bonheiden, Belgium

Status

Address

Imelda Hospital, Bonheiden

Bonheiden, ,

Sint-Jan, Brugge, Belgium

Status

Address

Sint-Jan

Brugge, , 8000

Algemeen Ziekenhuis Maria Middelares, Ghent, Belgium

Status

Address

Algemeen Ziekenhuis Maria Middelares

Ghent, ,

Jessa Hospital, Hasselt, Belgium

Status

Address

Jessa Hospital

Hasselt, ,

Sint-Jan, Oostende, Belgium

Status

Address

Sint-Jan

Oostende, , 8400

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