Hydrolyzed Egg and Tolerance Induction

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526863
• Other study ID #: 10.53.NRC
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: January 15, 2015
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 66 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Dietary Supplement:
• HA egg
Daily dose of HA egg or placebo for 6 months

Locations

Country	Name	City	State
Greece	University of Athens	Athens
Italy	University Hospital of Padua	Padua
Switzerland	Hochgebirgsklinik Davos	Davos Wolfgang

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive or negative result (objective and subjective symptoms) of a challenge test with egg		6 months	No
Secondary	compliance (product taken)		6 months	No
Secondary	skin prick test (sensitization to egg; size of wheal and flare)		6 months	No
Secondary	Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation		6 months	No
Secondary	Morbidity / Adverse Events		6 months	Yes