Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing
      sustained unresponsiveness to egg exposure in children.
    

Detailed description: 
      Food allergy affects 6-8 percent of children in the United States. In young children,
      reactions to egg can range from hives to severe life threatening allergic reactions called
      anaphylaxis. Current treatment for food allergy is complete avoidance of the food and to
      carry antihistamines and self-injectable epinephrine if an accidental reaction occurs.
      However, accidental exposure to allergens in processed foods may be difficult to avoid.
      Currently, several therapeutic strategies are being investigated to prevent and treat food
      allergies. Since immunotherapy injections for food allergy are associated with a high rate of
      allergic reactions, alternate approaches to treatment are needed. Oral (by mouth)
      immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of
      food allergies. The purpose of this study is to compare baked foods with egg versus (vs.) egg
      OIT. The intent of the study is to investigate if participants will be able to consume egg
      after taking baked foods with egg or egg OIT for a period of time and then stopping for a
      certain period. This is referred to as tolerance or sustained unresponsiveness. This study
      will evaluate the effectiveness of the egg OIT vs. baked egg by having each participant
      ingest egg white solid or baked foods with egg. This will be done over 2 years.

      This study will last 2 years. All eligible subjects will receive a baked egg oral food
      challenge (OFC). Those who pass the baked egg OFC will then have a 2 gm egg OFC. Those who
      react to the egg OFC will be randomized to Baked Egg or Egg OIT. Individuals who do not pass
      the initial baked egg OFC will be assigned to Egg OIT. Those who pass the egg OFC will not be
      eligible for the study and will be followed per site standard of care. All eligible and
      enrolled subjects will have a 1-year and a 2-year OFC.

      At selected visits, blood and urine collection, physical examination, prick skin tests, and
      atopic dermatitis and asthma evaluations will occur.
    

Intervention name(s): Egg Oral Immunotherapy; Baked Egg
Intervention type(s): Drug; Drug
Intervention description(s): Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.; Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
Other intervention name(s): Egg white solid
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Egg Allergy; Egg Oral Immunotherapy; Food Allergy