Follow up of LEAP Participants and Their Families (LEAP Trio)

Principal Investigator

Gideon Lack | Evelina Childrens Hospital | London, UK

Locations

Evelina Children's Hospital | London, United Kingdom

Study Code

ITN070AD

Study Status

Active

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.

Qualification

The following LEAP participants and family members are eligible to participate in LEAP Trio:

  • 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.
  • Siblings of LEAP participants.
  • Biological parents of LEAP participants.

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