Registry of Food Allergy Oral Immunotherapy Treatment
National Registry of Food Allergy Treatment
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
April 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 4, 2021
February 1, 2021
2.3 years
February 13, 2017
February 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of food allergy treatment
the percentage of patients who successfully reach the maintenance dose of food
3 years
Secondary Outcomes (2)
epinephrine use
3 years
factors associated with the failure to reach the target dose of food ingestion
3 years
Eligibility Criteria
Patients presenting to participating clinical sites with high probability of food allergy who choose to undergo food oral immunotherapy treatment.
You may qualify if:
- 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
You may not qualify if:
- pregnancy
- severe asthma
- poorly controlled atopic dermatitis
- eosinophilic esophagitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Food Allergy Center of FL
Sarasota, Florida, 34239, United States
Related Publications (2)
Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001.
PMID: 24565775BACKGROUNDNachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1.
PMID: 25940735BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Windom, MD
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2017
First Posted
February 23, 2017
Study Start
April 15, 2017
Primary Completion
August 20, 2019
Study Completion
December 31, 2020
Last Updated
February 4, 2021
Record last verified: 2021-02