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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526863

Enrollment

Registered

2012-02-06

Start date

2012-10-31

Completion date

2014-07-31

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Allergy, Egg

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.

Interventions

DIETARY_SUPPLEMENTHA egg

Daily dose of HA egg or placebo for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 66 Months

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

Design outcomes

Primary

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

Secondary

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

Countries

Greece, Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026