Clinical trial NCT01379651: Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
Official title: Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: - Egg Hypersensitivity
Keywords: Egg allergy,specific oral tolerance induction
Lead sponsor: Ospedale Buon Consiglio Fatebenefratelli
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: Inclusion Criteria:

* at least 1 anaphylactic reaction (grade 3, 4 and 5 according to Sampson's grading after accidental exposure to trace amounts of egg or egg-derivative products, requiring emergency treatment, at least 1 year before enrollment
* demonstration of egg white specific IgE by the skin prick test (SPT), end-point SPT, raw egg white prick-by-prick (PP) and egg white-specific IgE determination
* positive double-blind placebo-controlled food challenge (DBPCFC) at a dose of less than 0.9 ml of raw emulsion egg

Exclusion Criteria:

* age below 5 years
* poorly controlled asthma
* parents with a history of unreliable management of complications and treatment.

Primary outcomes:
measure: Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Benevento
country: Italy
facility: Unit of Pediatrics, Fatebenefratelli Hospital
Study officials:
affiliation: Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
name: Iride Dello Iacono, pediatrician
role: STUDY_DIRECTOR
References:
citation: Calvani M, Giorgio V, Miceli Sopo S. Specific oral tolerance induction for food. A systematic review. Eur Ann Allergy Clin Immunol. 2010 Feb;42(1):11-9.
citation: Sampson HA. Anaphylaxis and emergency treatment. Pediatrics. 2003 Jun;111(6 Pt 3):1601-8.
citation: Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. doi: 10.1016/j.jaci.2005.05.048.
citation: Barbi E, Berti I, Longo G. Food allergy: from the of loss of tolerance induced by exclusion diets to specific oral tolerance induction. Recent Pat Inflamm Allergy Drug Discov. 2008 Nov;2(3):212-4. doi: 10.2174/187221308786241875.