Registry of Food Allergy Oral Immunotherapy Treatment

National Registry of Food Allergy Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03059589

Enrollment

2000

Registered

2017-02-23

Start date

2017-04-15

Completion date

2020-12-31

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

Keywords

food anaphylaxis, peanut anaphylaxis, food oral immunotherapy, food allergy, food allergy treatment

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
efficacy of food allergy treatment	3 years	the percentage of patients who successfully reach the maintenance dose of food

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results