EGGSOTI
Specific Oral Tolerance Induction in Children With Severe Egg Allergy: A Randomized Controlled Trial Using a 6 Months Protocol
Sponsor study identifier
interventional
20
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 2010
Actual (reported)June 2010
Actual (reported)June 20, 2011
Actual (reported)June 23, 2011
Actual (reported)August 30, 2011
Actual (reported)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
Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP
Baseline and 6 months
Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
controls were kept on an egg-free diet for 6 months
Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Unit of Pediatrics, Fatebenefratelli Hospital
Benevento, Benevento, 82100, Italy
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.
Sampson HA. Anaphylaxis and emergency treatment. Pediatrics. 2003 Jun;111(6 Pt 3):1601-8.
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.
Iride Dello Iacono, pediatrician
Unit of Pediatrics, Fatebenefratelli Hospital, Benevento, Italy
20 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2011
First Posted
June 23, 2011
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
Contact the study team to confirm eligibility.
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.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
September 20, 2011
Results First Posted
August 30, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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