Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy (EGGSOTI)
|- Egg Hypersensitivity||Other: Specific oral tolerance induction||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol|
- 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.
- 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.
|Study Start Date:||January 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Specific oral tolerance induction
Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
Other: Specific oral tolerance induction
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Other Name: SOTI
No Intervention: control
controls were kept on an egg-free diet for 6 months
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379651
|Unit of Pediatrics, Fatebenefratelli Hospital|
|Benevento, Italy, 82100|
|Study Director:||Iride Dello Iacono, pediatrician||Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy|