Hydrolyzed Egg and Tolerance Induction

Not Applicable

Completed

• Conditions: Allergy
• Interventions: Dietary Supplement: HA egg

• Registration Number: NCT01526863
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Study Start: 2012-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	HA egg	-
HA egg	HA egg	-

Primary Outcome Measures

Name	Time	Method
positive or negative result (objective and subjective symptoms) of a challenge test with egg	6 months

Secondary Outcome Measures

Name	Time	Method
compliance (product taken)	6 months
Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation	6 months
skin prick test (sensitization to egg; size of wheal and flare)	6 months
Morbidity / Adverse Events	6 months

Trial Locations

Locations (3)

University of Athens; 🇬🇷 Athens, Greece

University Hospital of Padua; 🇮🇹 Padua, Italy

Hochgebirgsklinik Davos; 🇨🇭 Davos Wolfgang, Switzerland