Registry of Food Allergy Oral Immunotherapy Treatment

Food Allergy Support Team2,000 enrolled

Overview

The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Food Allergy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food, * no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food Exclusion Criteria: * pregnancy * severe asthma * poorly controlled atopic dermatitis * eosinophilic esophagitis

Locations (1)

Food Allergy Center of FL

Sarasota, Florida, United States

Outcomes

Primary Outcomes

efficacy of food allergy treatment

the percentage of patients who successfully reach the maintenance dose of food

Time frame: 3 years

Secondary Outcomes

epinephrine use

The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine.

Time frame: 3 years

factors associated with the failure to reach the target dose of food ingestion

Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions.

Time frame: 3 years

Data from ClinicalTrials.gov

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