Clinical Trial: Hydrolyzed Egg and Tolerance Induction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Nestlé

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • compliance (product taken) [ Time Frame: 6 months ]
  • skin prick test (sensitization to egg; size of wheal and flare) [ Time Frame: 6 months ]
  • Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation [ Time Frame: 6 months ]
  • Morbidity / Adverse Events [ Time Frame: 6 months ]


Original Secondary Outcome:

  • compliance (product taken) [ Time Frame: 6 months ]
  • skin prick test (sensitization to egg; size of wheal and flare) [ Time Frame: 6 months ]
  • Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation [ Time Frame: 6 months ]


Information By: Nestlé

Dates:
Date Received: January 30, 2012
Date Started: October 2012
Date Completion:
Last Updated: January 15, 2015
Last Verified: January 2015