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

Egg Hypersensitivity Clinical Trial

— EGGSOTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379651
• Other study ID #: FBFBN
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 20, 2011
• Last updated: September 19, 2011
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: Ospedale Buon Consiglio Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Egg Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Specific oral tolerance induction
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg

Locations

Country	Name	City	State
Italy	Unit of Pediatrics, Fatebenefratelli Hospital	Benevento

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Buon Consiglio Fatebenefratelli

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Review. — View 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. Review. — View Citation

Sampson HA. Anaphylaxis and emergency treatment. Pediatrics. 2003 Jun;111(6 Pt 3):1601-8. Review. — View Citation

Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg	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.	baseline and 6 months	Yes
Secondary	Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP	Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.	Baseline and 6 months	Yes