Follow up of LEAP Participants and Their Families

Trial ID or NCT#

NCT03546413

Status

not recruiting iconNOT RECRUITING

Purpose

This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention.

Official Title

Follow up of Learning Early About Peanut Allergy (LEAP) Participants and Their Families: LEAP Trio (ITN070AD)

Eligibility Criteria

Ages Eligible for Study: Older than 1
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Inclusion Criteria - LEAP Participants:
    1. * 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.
  3. Inclusion Criteria - LEAP Siblings:
    1. * 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.
  5. Inclusion Criteria - LEAP Parents:
    1. * 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:
  1. * There are no exclusion criteria for LEAP Participants, LEAP Siblings, LEAP Parents
View All Criteria
Show Less

Investigator(s)

Michelle Huffaker, MD
Michelle Huffaker, MD
Allergist, Immunologist
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine

View on ClinicalTrials.gov