Egg Hypersensitivity Clinical Trial
Official title:
Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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