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Completed

NCT Number: NCT01526863

Hydrolyzed Egg and Tolerance Induction

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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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

12 month–66 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Athens, Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HA egg

Dietary Supplement

Daily dose of HA egg or placebo for 6 months

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. compliance (product taken)

    Time frame: 6 months

  2. skin prick test (sensitization to egg; size of wheal and flare)

    Time frame: 6 months

  3. Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation

    Time frame: 6 months

  4. Morbidity / Adverse Events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2012
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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