NCT01379651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 30, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

2.4 years

First QC Date

June 20, 2011

Results QC Date

June 24, 2011

Last Update Submit

September 19, 2011

Conditions

- Egg Hypersensitivity

Keywords

Egg allergy,specific oral tolerance induction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP

    Baseline and 6 months

Study Arms (2)

Specific oral tolerance induction

EXPERIMENTAL

Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen

Other: Specific oral tolerance induction

control

NO INTERVENTION

controls were kept on an egg-free diet for 6 months

Interventions

Specific oral tolerance inductionOTHER

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

Also known as: SOTI
Specific oral tolerance induction

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Pediatrics, Fatebenefratelli Hospital

Benevento, Benevento, 82100, Italy

Location

Related Publications (4)

  • 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.

    PMID: 20355360BACKGROUND

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

    PMID: 12777599BACKGROUND

  • 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.

    PMID: 16455349BACKGROUND

  • 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.

    PMID: 19076011BACKGROUND

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr. Iride Dello Iacono
Organization
Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
iridedello@hotmail.com
+39 824 771111

Study Officials

  • Iride Dello Iacono, pediatrician

    Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatrician

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 23, 2011

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 20, 2011

Results First Posted

August 30, 2011

Record last verified: 2011-09

Locations

IT(1)