The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.
Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Percentage of Subjects Who Develop Desensitization
The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.
Time frame: 40 weeks
Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped
The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.
Time frame: 4 weeks
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