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Trial record 45 of 58 for:    Recruiting, Not yet recruiting, Available Studies | "Food Hypersensitivity"

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

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ClinicalTrials.gov Identifier: NCT02487420
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Jessa Hospital
Algemeen Ziekenhuis Maria Middelares
Imelda Hospital, Bonheiden
AZ Sint-Jan AV
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Egg Hypersensitivity Behavioral: shorter or longer period of specific dietary restrictions Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Trapsgewijze Ei-tolerantie-inductie Bij Kippenei-allergische Kinderen (TETI Studie)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. time to complete egg tolerance [ Time Frame: 18 to 30 months ]
    raw egg tolerance (eg in chocolate mousse)


Secondary Outcome Measures :
  1. Measurement of specific IgE to egg white components to predict complete egg tolerance [ Time Frame: 18 to 30 months ]


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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487420


Contacts
Contact: Dominique MA Bullens, MD, PhD +32/16/341338 Dominique.Bullens@uzleuven.be

Locations
Belgium
University Hospital of Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Dominique Bullens, MD, PhD         
Imelda Hospital, Bonheiden Recruiting
Bonheiden, Belgium
Contact: Katrien Coppens, MD         
Sint-Jan Recruiting
Brugge, Belgium, 8000
Contact: Kate Sauer, MD         
Algemeen Ziekenhuis Maria Middelares Recruiting
Ghent, Belgium
Contact: Jasmine Leus, MD         
Jessa Hospital Recruiting
Hasselt, Belgium
Contact: Raes Marc, MD         
Sint-Jan Recruiting
Oostende, Belgium, 8400
Contact: Kate Sauer, MD         
Sponsors and Collaborators
Dominque Bullens
Jessa Hospital
Algemeen Ziekenhuis Maria Middelares
Imelda Hospital, Bonheiden
AZ Sint-Jan AV
Investigators
Principal Investigator: Dominique MA Bullens, MD, PhD UZ Leuven

Responsible Party: Dominque Bullens, MD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02487420     History of Changes
Other Study ID Numbers: S57588
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will be analysed and grouped before release

Additional relevant MeSH terms:
Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate