Registry of Food Allergy Oral Immunotherapy Treatment

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.

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Food Allergy Center of FL

Sarasota, Florida, 34239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

efficacy of food allergy treatment

Time frame: 3 years

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

Secondary outcomes

epinephrine use

Time frame: 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

Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Food Allergy Support Team

Other

Registry information

Official study title

National Registry of Food Allergy Treatment

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Feb 23, 2017
Registry last updated: Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed