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.
Background: Food allergies and specifically peanut allergy (PA) are 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 demonstrated that children who consumed peanut in the LEAP study remained protected against developing peanut allergy after cessation of peanut consumption for a period of 12 months. This LEAP Trio cohort study, a longer-term follow-up of the LEAP study participants, assessed whether the benefits of regular early-life peanut consumption are maintained over many years when peanut consumption is ad libitum (in the amount and frequency chosen by the individual participant). The three cohorts in LEAP-Trio include: * LEAP Participants (NCT00329784, NCT01366846) * their Siblings and * their Parents The study began on July 5, 2018, with data collection continuing until August 31, 2022. This allowed for the enrollment of former LEAP participants aged 12 years.: • The enrollment phase was 217 weeks (4 years, 2 months). --The LEAP siblings and parents were enrolled concurrently with the LEAP participant. • Study participation was defined as a single visit (Visit 144 months); however, more than one clinic appointment might have been required to complete all assessments and were required to be completed within 8 weeks of the in-person visit. Due to COVID-19, telephone visits were undertaken when participants were not able to or did not wish to come into the clinic or have a home visit. The visit window did not apply to the telephone visit. Participants who underwent a telephone visit were invited to subsequently undergo an in-person clinic visit or home visit. Participant assessments included 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).
Study Type
OBSERVATIONAL
Enrollment
1,868
Evelina London Children's Hospital
London, United Kingdom
Percentage of LEAP Participants With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Time frame: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of Younger Siblings With Peanut Sensitization
Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria: Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm
Time frame: Assessments were performed on consented siblings at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents
At LEAP Trio Visit 144, participants were asked to provide responses to questions about their peanut protein consumption. Responses obtained at LEAP Trio Visit 144 were based on the recollection of peanut consumption during the 4 weeks prior to the LEAP Trio study Visit 144.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents
Skin prick tests were performed to assess participants for potential peanut allergy, select food allergens, and select aeroallergens
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents
Participants had blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings
Eczema severity was assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Eczema
Participants were classified as having eczema using standard methodology. Participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Asthma
Participants were classified as having asthma if they meet at least one of the following definitions: 1. Participant report of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months; or required one visit to a physician in the previous 24 months; or occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. 2. Participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller) 3. Participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Perennial Rhinitis
Participants were considered to have perennial rhinitis if they demonstrated a sensitization to the aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents With Seasonal Rhinitis
Participants were considered to have seasonal rhinitis if they demonstrated a sensitization to a seasonal aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the allergen during the relevant season. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Younger Siblings, Older Siblings and Parents With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Time frame: Assessments were performed on consented family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings and Older Siblings With at Least One Peanut-related Adverse Event
Peanut-related adverse events were reported from reactions experienced during or within 30 days after the LEAP Trio Visit 144 peanut oral food challenge (peanut OFC)
Time frame: Within 30 days after peanut OFC performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).