Registry of Food Allergy Oral Immunotherapy Treatment
- Conditions
- Food Allergy
- Registration Number
- NCT03059589
- Lead Sponsor
- Food Allergy Support Team
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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
- pregnancy
- severe asthma
- poorly controlled atopic dermatitis
- eosinophilic esophagitis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of food allergy treatment 3 years the percentage of patients who successfully reach the maintenance dose of food
- Secondary Outcome Measures
Name Time Method epinephrine use 3 years 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.
factors associated with the failure to reach the target dose of food ingestion 3 years Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions.
Trial Locations
- Locations (1)
Food Allergy Center of FL
🇺🇸Sarasota, Florida, United States
Food Allergy Center of FL🇺🇸Sarasota, Florida, United States