Follow up of LEAP Participants and Their Families

Study Overview
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Brief Summary
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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.

Detailed Description
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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 August 31, 2022. This will allow for the enrollment of former LEAP participants aged 12 years.: The enrollment phase will be 234 weeks (4 years, 6 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. 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).

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

Conditions
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Peanut Allergy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LEAP Participants: Peanut Avoidance<br>Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. Target accrual is 316. | |
| LEAP Participants: Peanut Consumption<br>Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. Target accrual is 314 | |
| Younger Siblings: Peanut Avoidance<br>Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. Target accrual is 222. | |
| Younger Siblings: Peanut Consumption<br>Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. Target accrual is 207. | |
| Older Siblings: Peanut Avoidance<br>Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study. Target accrual is 153. | |
| Older Siblings: Peanut Consumption<br>Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. Target accrual is 164. | |
| Parents: Peanut Avoidance<br>Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study Target accrual is 474. | |
| Parents: Peanut Consumption<br>Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study. Target accrual is 471. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of LEAP Participants with Peanut Allergy at 144 months of Age | Peanut allergy status will be determined by available data collected at enrollment in peanut oral food challenge, peanut consumption questionnaire, skin prick test to peanut, specific-IgE to peanut and specific-IgE to individual peanut components Ara h1, Ara h2 and Ara h3. This comparison will evaluate whether the consumption of peanut starting in infancy induces long-lasting tolerance to peanut. (Reference: NCT00329784) | At age 144 months | 
| Percentage of Participants with Peanut Sensitization Among Younger Siblings of LEAP Participants who Resided in the Home of the LEAP Participant on or before LEAP Visit 60 | Peanut sensitization will be defined as: Specific-IgE ≥0.35kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1kU/L, or Skin prick test wheal to peanut ≥3mm (Reference: NCT00329784) | At enrollment. Additional visits may be performed to complete collection of all assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average weekly peanut protein consumption prior to Visit 144 for LEAP Participants, Younger Siblings, Older Siblings, and Parents | Peanut consumption questionnaire responses to the question for average peanut protein consumption per week for the 4 weeks prior to Visit 144 will be used in the analysis. | 4 weeks prior to Visit 144 | 
| Peanut skin prick test wheal size for LEAP Participants, Younger Siblings, Older Siblings, and Parents | Participants will be assessed for potential peanut allergy, select food allergens, and select aeroallergens. | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Peanut specific-IgE measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents | Participants will have blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| SCORAD score for the eczema severity in LEAP Participants, Younger Siblings and Older Siblings | Eczema severity will be assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types 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 | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents with Eczema | Participants will be classified as having eczema using standard methodology. Participants will be assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types 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. | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents with Asthma | Participants will be classified as having asthma if they meet at least one of the following definitions: if the participant has a history of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, required one visit to a physician in the previous 24 months, and occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller) participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests. | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents with Perennial Rhinitis | Participants will be classified as having perennial rhinitis using standard methodology. Participants will be considered to have perennial rhinitis if they demonstrate a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen (perennial. Sensitization to the relevant allergen will be defined as: Allergen specific IgE ≥ 0.35 kU/L, or Skin prick test wheal size to allergen ≥ 3 mm. | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents with Seasonal Rhinitis | Participants will be classified as having seasonal rhinitis using standard methodology. Participants will be considered to have seasonal rhinitis if they demonstrate a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen during the relevant season (seasonal). Sensitization to the relevant allergen will be defined as: Allergen specific IgE ≥ 0.35 kU/L, or Skin prick test wheal size to allergen ≥ 3 mm | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Younger Siblings, Older Siblings and Parents with Peanut Allergy | Peanut allergy status will be determined by available data collected at enrollment in peanut oral food challenge, peanut consumption questionnaire, skin prick test to peanut, specific-IgE to peanut and specific-IgE to individual peanut components Ara h1, Ara h2 and Ara h3. | At enrollment. Additional visits may be performed to complete collection of all assessments | 
| Percentage of LEAP Participants, Younger Siblings and Older Siblings with at least one peanut-related adverse event | Peanut-related adverse events will be reported from reactions experienced during or within 30 days after the peanut oral food challenge. | At enrollment. Additional visits may be performed to complete collection of all assessments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food, peanut, allergy, prevention