An interventional study of Egg white protein in Food Hypersensitivity, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in United States. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2018-03-26.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's enrollment of 13 is below the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Egg Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance.
Drug: Egg white protein
Egg white protein powder
Also known as: Egg OIT
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
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
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
| Milestone | Egg White Protein Powder |
|---|---|
| Started | 13 |
| Completed | 9 |
| Not completed | 4 |
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.
| subjects with no symptoms on DBPCFC | Egg White Protein Powder |
|---|---|
| Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg | 9 |
Wheal size on egg protein skin prick test at the end of egg OIT treatment compared with at baseline.
| mm | Egg White Protein Powder |
|---|---|
| Egg Protein Skin Prick Test After Egg OIT | 1.8 (0 to 9) |
Measure of serum CAP-FEIA to egg from subjects on egg OIT after completion of treatment compared to baseline
| ku/L | Egg White Protein Powder |
|---|---|
| Serum CAP-FEIA to Egg | 4.7 (0.35 to 8.4) |
Collected over 24-60 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Egg White Protein Powder | 0/13 (0%) | 0/13 (0%) | 12/13 (92.3%) |
| Event | Egg White Protein Powder |
|---|---|
| Erythematous rashSkin and subcutaneous tissue disorders | 6/13 |
| Abdominal painGastrointestinal disorders | 5/13 |
| Oropharyngeal itchRespiratory, thoracic and mediastinal disorders | 5/13 |
| VomitingGastrointestinal disorders | 4/13 |
| HivesSkin and subcutaneous tissue disorders | 3/13 |
| DiarrheaGastrointestinal disorders | 3/13 |
| SneezingRespiratory, thoracic and mediastinal disorders | 2/13 |
| Skin itchSkin and subcutaneous tissue disorders | 1/13 |
| Lip or eye swellingSkin and subcutaneous tissue disorders | 1/13 |
| RhinorrheaRespiratory, thoracic and mediastinal disorders | 1/13 |
| Age, Continuous(years) | Egg White Protein Powder |
|---|---|
| Mean | 6.6 (3.6 to 13.6) |
| Sex: Female, Male(Participants) | Egg White Protein Powder |
|---|---|
| Female | 5 |
| Male | 8 |
Plan to share: No
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →