Induction of Tolerance Through Early Introduction of Peanut in High-Risk Children (ITN032AD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum
研究概览
简要总结
This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema.
This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
详细描述
Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.
Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.
Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.
Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to consume solid food
- •Allergy to eggs and/or severe eczema
- •Informed consent obtained from parent or guardian.
排除标准
- •Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
- •Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
- •Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
- •Investigator-suspected allergy to peanut protein
- •Investigator-suspected allergy to peanut protein in care provider or current household member.
- •Diagnosis of persistent asthma
- •ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
- •BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
- •Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
- •Unwillingness or inability to comply with study requirements and procedures
研究组 & 干预措施
Peanut Consumption Group
Participants on this arm will consume peanut protein.
干预措施: Peanut Consumption Group (Biological)
Peanut Avoidance Group
Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.
结局指标
主要结局
Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum
时间窗: 60 months
At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined
时间窗: 60 months
At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.
次要结局
- SCORAD at 60 Months(60 months)
- Number of Participants With Asthma at 60 Months(60 months)
- Number of Participants With Rhinitis at 60 Months(60 months)
- Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm(60 months)
- Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L(60 months)