Hydrolyzed Egg and Tolerance Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526863
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : January 16, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Allergy Dietary Supplement: HA egg Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: HA egg
Daily dose of HA egg or placebo for 6 months
Active Comparator: HA egg Dietary Supplement: HA egg
Daily dose of HA egg or placebo for 6 months

Primary Outcome Measures :
  1. positive or negative result (objective and subjective symptoms) of a challenge test with egg [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 66 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526863

University of Athens
Athens, Greece, 11527
University Hospital of Padua
Padua, Italy, 35128
Hochgebirgsklinik Davos
Davos Wolfgang, Switzerland, 7265
Sponsors and Collaborators
Study Chair: Nikolaos Papadopoulos, Prof. University of Athens, Greece
Principal Investigator: Antonella Muraro, Prof University Hospital of Padua, Italy
Principal Investigator: Roger Lauener, Prof. Hochgebirgsklinik Davos, Switzerland
Principal Investigator: Stavroula Giavi, Dr. University of Athens, Greece

Responsible Party: Nestlé Identifier: NCT01526863     History of Changes
Other Study ID Numbers: 10.53.NRC
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015

Keywords provided by Nestlé: