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Completed

NCT Number: NCT01379651

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

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.

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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Unit of Pediatrics, Fatebenefratelli Hospital

Benevento, 82100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific oral tolerance induction

Other

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

Other names: SOTI

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

    Time frame: baseline and 6 months

    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 outcomes

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

    Time frame: Baseline and 6 months

    Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.

Sponsors and collaborators

Lead sponsor

Ospedale Buon Consiglio Fatebenefratelli

Other

Registry information

Official study title

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

Acronym: EGGSOTI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2011
Registry last updated
Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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