Hydrolyzed Egg and Tolerance Induction

Nestlé

Status: Completed

Conditions: Allergy

Treatments: Dietary Supplement: HA egg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526863

10.53.NRC

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 12 to 66 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: HA egg

HA egg

Active Comparator group

Treatment:

Dietary Supplement: HA egg