Food Hypersensitivity
Conditions
Keywords
Egg allergy
Brief 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.
Detailed description
Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie (\ 70 mg of egg protein) or a bite of a cake (\ 55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.
Interventions
DRUGEgg white protein
Egg white protein powder
Sponsors
University of North Carolina, Chapel Hill
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg | 24-60 months | Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is \< 7 kU/L or 90% of entry level IgE or SPT \<= 5mm with a maximum treatment period of 60 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Egg Protein Skin Prick Test After Egg OIT | 24-60 months | Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline. |
| Serum CAP-FEIA to Egg | 24-60 months | Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Egg White Protein Powder Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Egg White Protein Powder |
|---|---|
| Age, Continuous | 6.6 years |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 12 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg
Subjects will have a double-blind, placebo-controlled food challenge (DBPCFC) to egg after at least 24 months of egg OIT when the IgE to egg is \< 7 kU/L or 90% of entry level IgE or SPT \<= 5mm with a maximum treatment period of 60 months.
Time frame: 24-60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Egg White Protein Powder | Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg | 9 subjects with no symptoms on DBPCFC |
Secondary
Egg Protein Skin Prick Test After Egg OIT
Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.
Time frame: 24-60 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Egg White Protein Powder | Egg Protein Skin Prick Test After Egg OIT | 1.8 mm |
Secondary
Serum CAP-FEIA to Egg
Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline
Time frame: 24-60 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Egg White Protein Powder | Serum CAP-FEIA to Egg | 4.7 ku/L |