Trial document





This trial has been registered retrospectively.
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  DRKS00005668

Trial Description

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Title

Hen's Egg Allergy Prevention Study

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Trial Acronym

HEAP Study

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URL of the Trial

http://www.charite-ppi.de/aktuelles/klinische_studien/huehnereiallergie_praeventionsstudie/

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Brief Summary in Lay Language

Hen's egg allergy is a common disease in childhood. It develops frequently within the first two years of life. Clinical reactions range from mild skin symptoms to severe, sometimes life threatening reactions. Moreover, hen's egg allergy is predictive for the development of respiratory allergies later in life. Currently experts have no evidence to justify recommendations about either withholding or encouraging hen's egg feeding after four months once weaning has commenced. Therefore, the purpose of this study is to investigate whether early feeding or avoidance of hen's egg will prevent the development of hen's egg allergy.

The development of hen's egg allergy will be monitored in two groups of children, the first will receive early and continuous hen's egg feeding and the second will completely avoid hen's egg. Patients will be randomised into the feeding or avoidance group. Children in the feeding group will receive hen's egg three times a week starting after 4 of age when weaning has commenced. Children in the avoidance group will receive rice powder. Before intervention and at one year of age the presence of allergy antibodies to hen's egg will be determined in all children. Oral food challenges will be performed in children with elevated allergy antibodies to hen's egg in order to assess the clinical reactivity to hen's egg. All children will be followed up until the age of three.

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Brief Summary in Scientific Language

Hen's egg allergy is a common disease in childhood. It develops frequently within the first two years of life. Clinical reactions range from mild skin symptoms to life threatening anaphylaxis. Moreover, hen's egg allergy is predictive for the development of respiratory allergies later in life. Currently the evidence does not justify recommendations about either withholding or encouraging exposure to potentially allergenic foods after four months once weaning has commenced, irrespective of atopic heredity. The purpose of this study is to investigate whether early feeding or avoidance of hen's egg will prevent the development of hen's egg allergy. Moreover, the mechanism underlying the oral tolerance development will be investigated.

800 children will be recruited at birth and randomised into a "hen's egg feeding" or "avoidance" group. Starting after four months of age once weaning has commenced, children will receive verum powder (containing 2.5 g of hen's egg protein) or placebo powder (containing rice powder) three times a week. At birth (cord blood), before intervention and at one year of age, blood will be obtained and sensitisation to hen's egg allergens will be determined. Standardized questionnaires will be performed at these points. In children with elevated hen's egg-specific IgE antibodies double blind, placebo-controlled food challenge tests will be performed in order to determine clinical relevant hen's egg allergy.
All children will be followed up until the age of three.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005668
  •   2014/01/28
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  •   yes
  •   Approved
  •   EA2/006/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   hen's egg allergy
  •   T78.1 -  Other adverse food reactions, not elsewhere classified
  •   T78.0 -  Anaphylactic shock due to adverse food reaction
  •   L20.9 -  Atopic dermatitis, unspecified
  •   J45.9 -  Asthma, unspecified
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Interventions/Observational Groups

  •   Children will receive verum (2.5 g of hen's egg protein) three times a week starting after 4 months of age once weaning has commenced until 12 months of age. All children will be otherwise on a hen's egg free diet.
  •   Children will receive placebo (rice powder) three times a week starting after 4 months of age once weaning has commenced until 12 months of age. All children will be on a hen's egg free diet.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Sensitization to hen's egg protein at the age of 12 months will be determined through measurement of hen's egg-specific serum IgE (ImmunoCAP FEIA) at 12 months of age.

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Secondary Outcome

IgE-mediated hen's egg allergy at the age of 1 year confirmed by double blind placebo controlled oral hen's egg challenge in all children with hen's egg-specific IgE levels >0.35 kU/l (see primary endpoint).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/06/04
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   4   Months
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Additional Inclusion Criteria

birth of baby of > 35 weeks gestational age, birth weight > 2,5 kg, sufficient knowledge of German language

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Exclusion Criteria

birth of baby of < 35 weeks gestational age, birth weight < 2,5 kg

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, CVK, Pädiatrie m. S. Pneumologie und Immunologie, Kinderallergologisches Studienzentrum
    • Ms.  Prof. Dr.  Kirsten  Beyer 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, Pädiatrie m. S. Pneumologie und Immunologie, Kinderallergologisches Studienzentrum
    • Ms.  Ingrid  Lawnitzak 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Food Allergy and Anaphylaxis Network (FAAN)/FARE
    • 22102  McLean, VA
    • United States
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    • Pina e.V. Präventions- und Informationsnetzwerk Allergie/Asthma
    • 23538   Lübeck
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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