Peanut Allergy Oral Immunotherapy Desensitization

Study Overview
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Brief Summary
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The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system. Objectives To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure. To assess quality of life in peanut allergic subjects before and after desensitization. To compare serum metabolites in peanut allergic and non peanut allergic subjects.

Detailed Description
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Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future. Objectives: To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure. To assess quality of life in peanut allergic subjects before and after desensitization. To compare serum metabolites in peanut allergic and non peanut allergic subjects.

Official Title
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Peanut Allergy Oral Immunotherapy Desensitization

Conditions
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Peanut Allergy

Intervention / Treatment
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* Procedure: Peanut protein
* Procedure: Oat flour
* Drug: Antihistamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be between 5 and 10 years of age. Patients will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes after the ingestion of peanut,the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control; and a positive in vitro IgE [CAP-FEIA] result of >15 kU/L.. Patients will also be accepted into the study if they have a clinical reaction to peanut ingestion within the past 6 months, a positive skin prick test to peanut as defined previously, and an in vitro peanut IgE (CAP-FEIA) result of 7 kU/L or greater. Subjects must be free of any clinically significant disease which may interfere with study evaluations. Exclusion Criteria: Use of antihistamines or decongestant therapy 7 days prior to the clinic visit. (antihistamines eg. diphenhydramine, desloratadine etc or throughout the desensitization phase of the study. Patients who had an acute allergic reaction to food other than peanut, drugs, or stinging insects one month prior to the recruitment clinic visit Patients who have had a respiratory infection one month prior to the recruitment clinic visit. Patients with significant or uncontrolled asthma, (inhaled corticosteroids (fluticasone >500 mcg per day, ciclesonide >400 mcg per day or budesonide >800 mcg per day or the corresponding combination inhalers, oral prednisone in the preceding 1 month and FEV1 < 80% predicted). Nasal steroids, bronchodilators and leukotriene inhibitors will be permitted. If Prednisone is taken, it must also be stopped 1 month prior to blood being drawn if possible. Patients who received allergy injections (immunotherapy) to environmental allergens at any time in the past. Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines. Patients with problems related to compliance or following study instructions. Inability to come to hospital every 2 weeks for dose escalation.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Immunotherapy with placebo antihistamines<br>500 mg Peanut Protein with placebo antihistamines | Procedure: Peanut protein<br>* 500 mg<br>* Other names: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour;|
| Placebo Comparator: Double Placebo<br>Placebo (Oat flour) and placebo antihistamines | Procedure: Oat flour<br>* 500 mg Oat flour<br>|
| Active Comparator: Oral Immunotherapy with H1 and H2 antihistamines<br>500 mg Peanut Protein with Dosage of desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) and ranitidine be 5ml (15mg/ml=75 mg) po bid. | Procedure: Peanut protein<br>* 500 mg<br>* Other names: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour;Drug: Antihistamine<br>* Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid<br>* Other names: Desloratadine and Ranitidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Frequency and risk of adverse events, overall and stratified by organ system and severity | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life pre and post intervention | Pre and post OIT. | 6-12 months | 
| Eliciting doses to oral food challenge | Patients will be challenged at the end of the treatment period with peanut at the end to determine the change from threshold that they are able to tolerate. | 6-12 months |