N/A
N=13
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
Food Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00597558 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg — 9 subjects with no symptoms on DBPCFC
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Egg white protein (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg |
9 | — |
| SECONDARY Egg Protein Skin Prick Test After Egg OIT |
1.8 | — |
| SECONDARY Serum CAP-FEIA to Egg |
4.7 | — |
Summary
The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.
Eligibility Criteria
Inclusion Criteria
- Between 1 to 16 years of age
- Diagnosed egg allergy by CAP FEIA to egg of 5 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months.
- Having eaten egg in his/her diet prior to diagnosis
- A family that will be able to be compliant with all study visits
- All females of child bearing age must be using appropriate birth control
Exclusion Criteria
- History of anaphylaxis to egg
- Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 < 80% of predicted, or FEV1/FVC <75%, with or without controller medications
- Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- Diagnosed corn allergy
Data sourced from ClinicalTrials.gov (NCT00597558). 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.