Phase 2
N=20
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
- Egg Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01379651 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg — 9; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Specific oral tolerance induction (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg |
9; 0 | — |
| SECONDARY Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP |
5; 10 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01379651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.