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Abstract
LEAP Trio is a follow-up assessment of the LEAP randomized controlled study of early peanut consumption during which we found that in high-risk infants, sustained consumption of peanut beginning in the first 11 months of life was highly effective in preventing the development of peanut allergy. The primary objectives of LEAP Trio are threefold:
- To determine whether early consumption of peanuts by high-risk infants results in a decreased risk of peanut allergy in children at approximately 12 years of age.
- To understand the prevalence of sensitization in younger siblings of LEAP participants who consumed peanut compared to younger siblings of LEAP participants who avoided peanut.
- To assess the genetic influences on peanut allergy by characterizing the allergy status of the parents of LEAP participants.
LEAP participants are followed during an extended period of ad-libitum peanut consumption and then assessed for peanut allergy and other allergic outcomes at age 12. In addition, siblings will be randomly assigned to the intervention or control group based on the allocation of their LEAP participant siblings.
About This Study
LEAP Trio is a follow-up of the LEAP study of early peanut consumption during which we found that in high-risk infants, consumption of peanut beginning in the first 11 months of life was highly effective in preventing the development of peanut allergy. Our LEAP-ON study showed that this peanut allergy prevention persisted after one year of avoiding peanuts.
LEAP Trio will further investigate how early life introduction of peanuts may promote the development of tolerance to peanut allergen at age 12. The primary objectives of LEAP Trio are threefold:
- To investigate how early introduction of peanuts promotes the development of tolerance to peanut allergen at 12 years of age.
- To assess younger siblings of LEAP participants for peanut allergy.
- To examine parental characteristics that may impact the development of peanut allergy by identifying the allergy status of the parents of LEAP participants.
A study of siblings of LEAP participants will evaluate whether younger siblings of the LEAP consumers are at higher risk of peanut allergy compared to the younger siblings of LEAP avoiders due to the environmental exposure to peanut in conjunction with a lack of peanut consumption. Additional analysis will be done in older siblings.
Do you Qualify for this Clinical Trial?
The following LEAP participants and family members are eligible to participate in LEAP Trio:
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All participants who enrolled in LEAP, including those who were not part of the intent-to-treat population, are eligible to enroll in LEAP Trio once they reach an age of 9.5 years.
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Siblings of LEAP participants who resided in the same home as LEAP participant for at least one year during LEAP study.
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Biological parents of LEAP participants.