Registry of Food Allergy Oral Immunotherapy Treatment

NCT ID: NCT03059589

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2020-12-31

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.

Conditions

Food Allergy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food Allergy Support Team

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugh Windom, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Food Allergy Center of FL

Sarasota, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24565775 (View on PubMed)

Nachshon 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.

Reference Type: BACKGROUND

PMID: 25940735 (View on PubMed)

Other Identifiers

Mylan-16-004

Identifier Type: -

Identifier Source: org_study_id