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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Dietary supplement: HA egg

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • University of Athens
• Italy
  • Padua, Italy, 35128
    • University Hospital of Padua
• Switzerland
  • Davos Wolfgang, Switzerland, 7265
    • Hochgebirgsklinik Davos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: HA egg; Daily dose of HA egg or placebo for 6 months
Active Comparator: HA egg	Dietary supplement: HA egg; Daily dose of HA egg or placebo for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
positive or negative result (objective and subjective symptoms) of a challenge test with egg	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Chair: Nikolaos Papadopoulos, Prof., University of Athens, Greece; Principal Investigator: Antonella Muraro, Prof, University Hospital of Padua, Italy; Principal Investigator: Roger Lauener, Prof., Hochgebirgsklinik Davos, Switzerland; Principal Investigator: Stavroula Giavi, Dr., University of Athens, Greece

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Allergy; Egg
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 10.53.NRC