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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg white protein | Experimental | Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg white protein | Drug | Egg white protein powder |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24-60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Little Rock | Arkansas | 72202 | United States | ||
| UNC Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17208602 | Result | Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27. | |
| 21130382 | Result | Vickery BP, Pons L, Kulis M, Steele P, Jones SM, Burks AW. Individualized IgE-based dosing of egg oral immunotherapy and the development of tolerance. Ann Allergy Asthma Immunol. 2010 Dec;105(6):444-50. doi: 10.1016/j.anai.2010.09.030. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Egg White Protein Powder | Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Egg White Protein Powder | Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | subjects with no symptoms on DBPCFC | 24-60 months |
|
|
24-60 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Egg White Protein Powder | Egg allergic subjects who ingest oral egg white protein |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythematous rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
Endpoints were based on reaching certain lab criteria and thus the time on treatment varied from 24-60 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edwin Kim, Director | University of North Carolina at Chapel Hill | 919-843-9087 | edwinkim@email.unc.edu |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004527 | Egg Proteins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 24-60 months |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | Mean | Full Range | mm | 24-60 months |
|
|
|
| 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 | Posted | Mean | Full Range | ku/L | 24-60 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 12 |
| 13 |
| Skin itch | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lip or eye swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal itch | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal itch | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Eye itch | Eye disorders | Systematic Assessment |
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| Eye tearing | Eye disorders | Systematic Assessment |
|
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