The LEAP Trio Study

LEAP Trio is a long-term follow-up and assessment of the LEAP Study, a study of early peanut consumption, that will include the following groups:

  • LEAP and LEAP-On participants will be followed during an extended period following their original particpation in the LEAP and LEAP-On Studies and assessed for peanut and other allergies at the age of 12.

  • Siblings of LEAP participants will be assessed for peanut allergy. 

  • Parents of LEAP participants will be assessed to examine parental characteristics that may impact the development of food allergy.

The results of the LEAP study demonstrated that early introduction of peanut protein to children at high risk for developing peanut allergy was highly effective in preventing the development of peanut allergy. The 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 12 years of age and will serve as an additional safety evaluation of this oral immunotolerance therapy. 

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.

Is Your Child and Family Eligible to Participate in LEAP Trio?

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.