Hydrolyzed Egg and Tolerance Induction

Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo

The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.

Inclusion Criteria:

• Child of any ethnicity aged between 12 and 66 months at the time of enrolment

  • Positive Skin Prick Test (SPT) to egg white within the last 3 months
  • Either positive oral challenge OR convincing history, defined as an immediate (<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months
  • Having obtained his/her signed legal representative's informed consent.

Exclusion Criteria:

• History of severe anaphylaxis to egg

  • Significant pre-natal and/or post-natal disease
  • Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment
  • Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
  • Child whose parents / caregivers cannot be expected to comply with treatment
  • Child currently participating in another interventional clinical trial