Clinical Trial: Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy

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

Official Title: Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol

Brief Summary: To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.

Detailed Summary:

Oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg. The children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit juice or other). The dose was doubled at intervals of about one month in the day hospital. The increases in dose were customized for each subject based on the frequency and severity of side effects, or when an inter-current illness or asthma worsening intervened during the SOTI.

The investigators limited the SOTI protocol to six months for all patients, irrespective of the dose reached, in order to favor the adherence of families to the study.

When objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment was given. Subjects were discontinued from the study in case of severe adverse reactions (grade 5 reaction). Parents were advised they could telephone investigators 24 hours a day


Sponsor: Ospedale Buon Consiglio Fatebenefratelli

Current Primary Outcome: Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg [ Time Frame: baseline and 6 months ]

To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.


Original Primary Outcome: Maximal dose (ml) of raw egg emulsion tolerated after 6 months [ Time Frame: baseline and 6 months ]

To evaluate the efficacy of a 6-month SOTI protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.


Current Secondary Outcome: Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP [ Time Frame: Baseline and 6 months ]

Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.


Original Secondary Outcome: Change in Immunological Variables [ Time Frame: Baseline and 6 months ]

Before and after SOTI, we evaluated the change in the mean weal diameter in millimeters, using egg white SPTs, end-point SPT and PP. We also measured egg white IgE levels before and after SOTI.


Information By: Ospedale Buon Consiglio Fatebenefratelli

Dates:
Date Received: June 20, 2011
Date Started: January 2008
Date Completion:
Last Updated: September 19, 2011
Last Verified: September 2011