Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Commercially available peanut powder or peanut butter.
Oral food challenge threshold to peanut at week 52
compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months between subjects randomized to dietary peanut introduction and those randomized to avoidance.
Time frame: 52 weeks
1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance
Compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months of dietary peanut between subjects randomized to dietary peanut introduction first and those randomized to avoidance for 52 weeks and subsequent dietary peanut after week 52.
Time frame: 104 weeks
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
Comparison of OFC threshold (in milligrams) at 1 month of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Time frame: 56 weeks
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
Comparison of OFC threshold (in milligrams) at 2 months of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Time frame: 60 weeks
Safety with dietary introduction of peanut or avoidance
Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.
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Time frame: 52 weeks
Rate of discontinuation of dietary peanut
Number of participants randomized to dietary peanut who discontinue peanut.
Time frame: 104 weeks
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
Eczema severity as assessed by the SCORAD. The SCORAD has a component for patient measured outcomes and also provider assessment of eczema involvement. It has an overall score range of 0-100, where higher scores signify more severe eczema.
Time frame: 104 weeks
Peanut skin prick test wheal size
Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Time frame: 104 weeks