Hydrolyzed Egg and Tolerance Induction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01526863
First received: January 30, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention
Allergy
Dietary Supplement: HA egg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • positive or negative result (objective and subjective symptoms) of a challenge test with egg [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • compliance (product taken) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • skin prick test (sensitization to egg; size of wheal and flare) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Morbidity / Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Months to 66 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526863

Locations
Greece
University of Athens
Athens, Greece, 11527
Italy
University Hospital of Padua
Padua, Italy, 35128
Switzerland
Hochgebirgsklinik Davos
Davos Wolfgang, Switzerland, 7265
Sponsors and Collaborators
Nestlé
Investigators
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
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01526863     History of Changes
Other Study ID Numbers: 10.53.NRC
Study First Received: January 30, 2012
Last Updated: April 8, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Nestlé:
Allergy
Egg

ClinicalTrials.gov processed this record on September 15, 2014