Status:
COMPLETED
Hydrolyzed Egg and Tolerance Induction
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Allergy
Eligibility:
All Genders
12-66 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01526863
Start Date
October 1 2012
End Date
July 1 2014
Last Update
January 16 2015
Active Locations (3)
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1
University of Athens
Athens, Greece, 11527
2
University Hospital of Padua
Padua, Italy, 35128
3
Hochgebirgsklinik Davos
Wolfgang, Switzerland, 7265