Status:
COMPLETED
Egg Oral Immunotherapy
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Egg Hypersensitivity
Eligibility:
All Genders
6-17 years
Brief Summary
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Egg allergy is among the most common causes of IgE-m...
Detailed Description
The primary objective is to study the efficacy of baked egg oral immunotherapy. The secondary objectives are to determine the safety of allergen-specific immunotherapy for egg allergy through ingestio...
Eligibility Criteria
Inclusion
- Subjects must satisfy all inclusion criteria:
- Subjects must be age six to 17 years and have a history of egg allergy. Subjects shall maintain strict avoidance of consumption of all egg protein containing foods.
- Subjects will have a history (within the past six months) of a positive skin prick test to egg extract or an immunocap IgE level greater than 0.35 kU/L, and a positive allergic reaction history to egg within the past 12 months.
- a. Subjects will be accepted to the study if they have had a positive food challenge conducted at CHOP in the three months prior to the start of the study.
- Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- If a positive pregnancy test was obtained during the study, the subject will be asked to withdraw from the study.
- Informed consent of parent or legal guardian is required.
Exclusion
- Subjects will be excluded from the study if they meet any one of the following criteria:
- Ability to tolerate baked goods containing egg or the ability to tolerate a serving size of egg (6.3 grams of egg protein.)
- Pregnancy.
- A history of food protein induced enterocolitis syndrome to egg.
- A history of eosinophilic esophagitis, where egg has been identified as a causative food.
- A history of anaphylaxis requiring overnight hospitalization.
- A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management.
- A current diagnosis of severe persistent asthma \[FEV1 (forced expiratory volume in 1 second) \< 60% of predicted, as defined by NHLBI (National Heart, Lung, and Blood Institute) guidelines, despite current therapy\].
- A current diagnosis of severe atopic dermatitis.
- A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- Use of oral or injection steroids within one month of protocol initial visit.
- a. Should it become necessary for a subject to be on systemic corticosteroids while on the study, the subject will either be withdrawn from the study or the use of corticosteroids during the study will be taken into account during data analysis. The PI and lead investigators will make that decision based on the individual case.
- An acute illness within one week prior to the first dose of oral immunotherapy.
- Use of antihistamines within three days prior to Double blind placebo-controlled food challenge (DBPCFC).
- Use of chronic immunomodulatory therapy.
- Participation in another experimental therapy study.
- Participation in a study for the treatment of food allergy in the past 12 months.
- Inability to discontinue antihistamines for skin testing and food challenges.
- A positive pregnancy test.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01489553
Start Date
January 1 2012
End Date
October 1 2013
Last Update
October 22 2013
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