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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
  Purpose

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.


Condition Intervention Phase
- Egg Hypersensitivity
 Other: Specific oral tolerance induction
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Ospedale Buon Consiglio Fatebenefratelli:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379651

Locations
Italy
Unit of Pediatrics, Fatebenefratelli Hospital
Benevento, Italy, 82100
Sponsors and Collaborators
Ospedale Buon Consiglio Fatebenefratelli
Investigators
Study Director: Iride Dello Iacono, pediatrician Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
  More Information

Publications:

Responsible Party: Iride Dello Iacono, pediatrician, Ospedale Buon Consiglio Fatebenefratelli
ClinicalTrials.gov Identifier: NCT01379651     History of Changes
Other Study ID Numbers: FBFBN
Study First Received: June 20, 2011
Results First Received: June 24, 2011
Last Updated: September 19, 2011
Health Authority: Italy: National Institute of Health

Keywords provided by Ospedale Buon Consiglio Fatebenefratelli:
Egg allergy,specific oral tolerance induction

Additional relevant MeSH terms:
Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2013