Learning Early About Peanut Allergy (LEAP)

The LEAP study was a randomized controlled clinical trial in children at increased risk for peanut allergy, in which intervention using dietary introduction of peanut protein beginning in the first 4 to 11 months of life, continued until age 5 years, significantly decreased the frequency of peanut allergy later in childhood and modulated the immune response to peanuts. All subject phenotype data will be hosted on ITN Trial Share under the LEAP study.]]>
LEAP participants were selected based on family history of peanut allergy, and subjects exhibiting eczema, and/or egg allergy during the first year of life. Subjects with skin-prick test wheal size exceeding 5 mm to peanut extract were excluded for safety reasons.]]>
Children in LEAP randomized to peanut consumption arms and peanut avoidance arms were followed for 5 years, with oral food challenge to peanut as the primary endpoint. Following completion of this study, subjects were further consented for enrollment in LEAP-ON, which followed the subjects for an additional year of peanut avoidance. LEAP outcomes demonstrated successful desensitization and tolerance to peanut, with prevention of peanut allergy in the consumption cohort at 5 years of age, and sustained this result through the additional year (avoiding peanut ingestion) to 6 years of age.]]>