Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)
Condition: Peanut Allergic Subjects
MeSH terms: Peanut Hypersensitivity
Intervention: Peanut Oral Immunotherapy (POIT)
Intervention description: The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 5 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Peanut Allergy; Anaphylaxis; Desensitization; Food Allergy; Oral Immunotherapy

Summary:

      Many children who are allergic to peanuts do not outgrow their allergy and have very severe
      allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing,
      decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A
      severe allergic reaction can lead to death if not treated appropriately.

      The purpose of this study is to find out if there is a way to treat children with peanut
      allergy to help lower the risk of severe allergic reactions and also cause them to lose their
      allergy to peanuts. The approach that will used for this study is a process called
      "desensitization".

      Oral immunotherapy involves eating gradually increasing amounts of a food over several
      months. This is a research study because at this time peanut oral immunotherapy (OIT) is
      investigational. Peanut OIT (study drug) is investigational because it is not currently
      approved for clinical use by the Food and Drug Administration. There are no alternative safe
      and effective treatments for peanut induced allergic reactions other than peanut avoidance
      and treatment with medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at
             the time of the initial visit.

          -  The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test
             to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7
             kUA/L) measured within the past year.

          -  Significant clinical symptoms occurring within 120 minutes after ingesting peanuts
             during an observed DBPCFC. Patients who have not had previous oral exposure to peanut
             will be observed for a longer duration of 150 minutes because they may demonstrate a
             delayed immune response, given the lack of prior peanut exposure. Also, patients with
             a history of prior anaphylaxis will be observed for 150 minutes.

          -  Provide signed informed consent.

          -  Ability to follow-up regularly for scheduled appointments.

          -  Subjects will not be excluded if they are primarily Spanish speaking.

          -  Females of childbearing potential must be willing to practice an acceptable form of
             birth control throughout the protocol.

          -  Epinephrine injection training provided. Participant has current in-date epinephrine
             injector and parent/guardian demonstrates proper use

        Exclusion Criteria:

          -  History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or
             neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion,
             collapse, loss of consciousness; or incontinence)

          -  Currently participating in a study using an investigational new drug.

          -  Participation in any interventional study for the treatment of food allergy in the
             past 12 months or while participating in this study.

          -  Poor control or persistent activation of atopic dermatitis.

          -  Diagnosis of persistent asthma as defined by NHLBI criteria and currently being
             treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more
             than 2 days per week.

          -  Inability to discontinue antihistamines for skin testing and Oral Food Challenges
             (OFCs).

          -  Pregnant female.

          -  Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric
             illness or history of substance abuse.

          -  Active eosinophilic esophagitis requiring medication therapy during the past 12
             months.

          -  Subjects with known oat or wheat allergy

          -  Subjects currently on the build-up phase of environmental allergy immunotherapy
             injections

          -  Live more than 175 miles away from Texas Children's Hospital located in the Medical
             Center.