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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01379651
First received: June 20, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes

June 20, 2011
September 19, 2011
January 2008
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Maximal dose (ml) of raw egg emulsion tolerated after 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01379651 on ClinicalTrials.gov Archive Site
Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.
Change in immunological variables [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Egg Hypersensitivity
Other: Specific oral tolerance induction
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Other Name: SOTI
  • Experimental: Specific oral tolerance induction
    Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
    Intervention: Other: Specific oral tolerance induction
  • No Intervention: control
    controls were kept on an egg-free diet for 6 months

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01379651
FBFBN
Yes
Iride Dello Iacono, Ospedale Buon Consiglio Fatebenefratelli
Ospedale Buon Consiglio Fatebenefratelli
Not Provided
Study Director: Iride Dello Iacono, pediatrician Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
Ospedale Buon Consiglio Fatebenefratelli
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP