N/A
Completed N=1,868
Follow up of LEAP Participants and Their Families
Peanut Allergy
Source: ClinicalTrials.gov NCT03546413 ↗
Enrolled (actual)
1,868
Serious AEs
0.2%
Results posted
Mar 2024
Primary outcomePrimary: Percentage of LEAP Participants With Peanut Allergy — 15.4; 4.4; 84.6; 95.6 Percentage of Participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of LEAP Participants With Peanut Allergy |
15.4; 4.4; 84.6; 95.6 | <0.001 sig |
| PRIMARY Percentage of Younger Siblings With Peanut Sensitization |
20.0; 30.4; 80.0; 69.6 | 0.055 |
| SECONDARY Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents |
0.0; 5.2; 0.7; 2.6; 1.4; 1.3 | <0.001 sig |
| SECONDARY Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.131 |
| SECONDARY Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents |
0.2; 0.2; 0.1; 0.1; 0.1; 0.1 | 0.985 |
| SECONDARY SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | 0.225 |
| SECONDARY Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Eczema |
49.4; 51.4; 24.4; 31.9; 25.0; 29.7 | 0.658 |
| SECONDARY Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Asthma |
33.5; 31.6; 15.1; 11.1; 11.8; 22.7 | 0.659 |
| SECONDARY Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Perennial Rhinitis |
44.3; 42.7; 16.1; 17.3; 17.1; 26.4 | 0.729 |
| SECONDARY Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents With Seasonal Rhinitis |
49.0; 53.3; 18.7; 22.5; 25.0; 29.7 | 0.330 |
| SECONDARY Percentage of LEAP Younger Siblings, Older Siblings and Parents With Peanut Allergy |
4.8; 8.0; 0.0; 2.2; 0.3; 0.0 | 0.202 |
| SECONDARY Percentage of LEAP Participants, Younger Siblings and Older Siblings With at Least One Peanut-related Adverse Event |
5.9; 2.0; 2.6; 1.6; 0.0; 0.0 | 0.029 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03546413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.