Follow up of Learning Early About Peanut Allergy (LEAP) Participants and Their Families: LEAP Trio (ITN070AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,868
- 试验地点
- 1
- 主要终点
- Percentage of Younger Siblings With Peanut Sensitization
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •There are no exclusion criteria for LEAP Participants, LEAP Siblings, LEAP Parents
结局指标
主要结局
Percentage of Younger Siblings With Peanut Sensitization
时间窗: 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)).
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
Percentage of LEAP Participants With Peanut Allergy
时间窗: 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)).
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)
次要结局
- SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings(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(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(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)).)
- Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents(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(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(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(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(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)).)
- Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents(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 and Older Siblings With at Least One Peanut-related Adverse Event(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)).)