Follow up of LEAP Participants and Their Families

  • End date
    Jan 27, 2023
  • participants needed
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 4 March 2022
skin pricking


This prospective, cross-sectional study is designed to improve understanding of how early-life introduction of peanuts may promote the development of tolerance at 12 years of age and will serve as an additional safety evaluation of this nutritional intervention.


Background: Food allergies and peanut allergy (PA) are becoming increasingly common conditions and are an important public health concern. Dietary avoidance of peanut in early life has been recommended in many countries. However, there is evidence that the prevalence of PA is decreased in countries where children are fed peanut beginning at an early age.

The LEAP (Learning Early About Peanut allergy) Study (Protocol ITN032AD, NCT00329784) demonstrated that the early consumption of peanut in high-risk infants successfully reduced the prevalence of peanut allergy at five years of age when compared to peanut avoidance. The LEAP-On Study (Protocol ITN049AD, NCT01366846) was a follow-on study to LEAP and investigated whether children who consumed peanut remained protected against developing peanut allergy even after cessation of peanut consumption for a period of 12 months. The key finding of the LEAP studies is that early introduction and consumption of peanut until 60 months of age causes a reduction in peanut allergy that persists at 72 months of age, even with a 12-month period of avoidance.

This LEAP Trio cohort study:

This longer-term follow-up of the study participants will assess whether the benefits of regular early-life peanut consumption are maintained over many years when followed by consumption of peanut ad lib, or as much and as often as desired.

The three cohorts will include LEAP:

  • Participants (NCT00329784, NCT01366846)
  • Siblings and
  • Parents

The study will begin in 2018 with data collection continuing until December of 2020. This will allow for the enrollment of former LEAP participants aged 12 years.:

  • The enrollment phase will be 69 weeks (1 year, 4.25 months).

--The LEAP siblings and parents cohorts will be enrolled concurrently with the LEAP participant cohort.

  • Study participation phase will be 1 visit; however, more than one clinic appointment may be required to complete all assessments. The visit must be completed within 8 weeks of enrollment.

Participant assessments will include general medical, -dietary, -allergy (including but not limited to oral peanut food challenges for former LEAP participants and their siblings), and mechanistic assessments (involving the collection of biological specimens, a blood draw, skin prick testing, as examples, to explore hypotheses related to potential mechanisms of peanut allergy).

Condition Peanut Allergy
Clinical Study IdentifierNCT03546413
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on4 March 2022


Yes No Not Sure

Inclusion Criteria

Inclusion Criteria - LEAP Participants
Participation in LEAP
At least 9.5 years of age
Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw) procedure; and
Assent by child and informed consent by parent or legal guardian
Inclusion Criteria - LEAP Siblings
Sibling of LEAP participant
Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
Assent by child and informed consent by parent or legal guardian if child is younger than 16; siblings aged 16 and over will provide their own consent
Inclusion Criteria - LEAP Parents
Biological parent of LEAP participant
Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
Informed consent (for participants only returning a Questionnaire, informed consent will be implied)

Exclusion Criteria

There are no exclusion criteria for LEAP Participants, LEAP Siblings, LEAP Parents
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