Clinical Trial: Registry of Food Allergy Oral Immunotherapy Treatment
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]
Official Title: National Registry of 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 Summary: 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.
Sponsor: Food Allergy Support Team
Current Primary Outcome: efficacy of food allergy treatment [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Food Allergy Support Team
Dates:
Date Received: February 13, 2017
Date Started: March 15, 2017
Date Completion: August 2019
Last Updated: February 16, 2017
Last Verified: February 2017
