Status:
COMPLETED
Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Food Hypersensitivity
Eligibility:
All Genders
9-36 years
Phase:
PHASE2
Brief Summary
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut al...
Detailed Description
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies, it tends to be more persistent and its prevalence seems to be rising. Currently, there is no proven ...
Eligibility Criteria
Inclusion
- Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
- EITHER a positive skin prick test to peanuts or in vitro \[CAP-FEIA\] peanut immunoglobin E (IgE) level in the blood \> 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
- OR a positive prick skin test to peanuts and in vitro \[CAP-FEIA\] peanut IgE level \> 5 kU/L when there is no history of allergic reaction and no known peanut exposure
- Provision of signed informed consent
- Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge
Exclusion
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
- Currently participating in a study using an investigational new drug
- Participation in any interventional study for the treatment of food allergy in the past 12 months
- Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- Severe atopic dermatitis
- Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
- Inability to discontinue antihistamines for skin testing and OFCs
Key Trial Info
Start Date :
June 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00932828
Start Date
June 22 2009
End Date
February 1 2017
Last Update
May 24 2018
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599