Status:
COMPLETED
Oral Immunotherapy (OIT) for Peanut Allergy
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
1-6 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 subjects who have peanut allergy by lowering the risk of anaph...
Detailed Description
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no prov...
Eligibility Criteria
Inclusion
- Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
- The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal \>3.0 mm) and a positive in vitro IgE \[CAP-FEIA\] \> 7 kUA/L
- A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
- Provide signed informed consent
Exclusion
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- 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
- Poor control or persistent activation of atopic dermatitis
- Moderate to severe persistent asthma
- 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 oral food challenges (OFCs)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00815035
Start Date
April 1 2009
End Date
December 12 2016
Last Update
March 1 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599