Registry of Food Allergy Oral Immunotherapy Treatment

Food Allergy Support Team

Status: Completed

Conditions: Food Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT03059589

Mylan-16-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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