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Hydrolyzed Egg and Tolerance Induction

Primary Purpose

Allergy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HA egg
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Allergy, Egg

Eligibility Criteria

12 Months - 66 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Athens
  • University Hospital of Padua
  • Hochgebirgsklinik Davos

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

HA egg

Arm Description

Outcomes

Primary Outcome Measures

positive or negative result (objective and subjective symptoms) of a challenge test with egg

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2012
Last Updated
January 15, 2015
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01526863
Brief Title
Hydrolyzed Egg and Tolerance Induction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Allergy, Egg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
HA egg
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
HA egg
Intervention Description
Daily dose of HA egg or placebo for 6 months
Primary Outcome Measure Information:
Title
positive or negative result (objective and subjective symptoms) of a challenge test with egg
Time Frame
6 months
Secondary Outcome Measure Information:
Title
compliance (product taken)
Time Frame
6 months
Title
skin prick test (sensitization to egg; size of wheal and flare)
Time Frame
6 months
Title
Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation
Time Frame
6 months
Title
Morbidity / Adverse Events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
66 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Papadopoulos, Prof.
Organizational Affiliation
University of Athens, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonella Muraro, Prof
Organizational Affiliation
University Hospital of Padua, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger Lauener, Prof.
Organizational Affiliation
Hochgebirgsklinik Davos, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stavroula Giavi, Dr.
Organizational Affiliation
University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital of Padua
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Hochgebirgsklinik Davos
City
Davos Wolfgang
ZIP/Postal Code
7265
Country
Switzerland

12. IPD Sharing Statement

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Hydrolyzed Egg and Tolerance Induction

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