Hydrolyzed Egg and Tolerance Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

HA egg

Intervention Type DIETARY_SUPPLEMENT

Daily dose of HA egg or placebo for 6 months

HA egg

Group Type ACTIVE_COMPARATOR

HA egg

Intervention Type DIETARY_SUPPLEMENT

Daily dose of HA egg or placebo for 6 months

Interventions

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HA egg

Daily dose of HA egg or placebo for 6 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

66 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No