Title

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
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    egg ...
  • Study Participants

    29
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.
Study Started
Oct 31
2012
Primary Completion
Jul 31
2014
Study Completion
Jul 31
2014
Last Update
Jan 16
2015
Estimate

Dietary Supplement HA egg

Daily dose of HA egg or placebo for 6 months

Placebo Placebo Comparator

HA egg Active Comparator

Criteria

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
No Results Posted