Disease Management: Canadian Peanut Thresholds Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Peanut threshold dose
研究概览
简要总结
An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to peanut where some individuals react to trace doses, whereas others are able to tolerate larger doses. The purpose of this study is to determine the minimum threshold dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged 7-65 years will undergo a two-day, double blind placebo controlled food challenge. Participants will be gradually fed increasing amounts of peanut, or placebo, until objective allergic symptoms are observed. Statistical modelling of individual threshold doses will be used to determine a population threshold dose, or a level of peanut to which 90% of the peanut-allergic population will not react. Knowledge of threshold doses at an individual and population level is valuable in that it provides critical information for the management of peanut allergy by individuals, their caregivers and health professionals, as well as knowledge of allergen risks to public health agencies and the food industry.
详细描述
Overview
This study protocol will be modeled on a consensus protocol developed with the input of clinical allergists and other allergy stakeholders to standardize threshold challenge studies [5-8]. As per protocol, 30 patients with a known or convincing history of peanut allergy will be recruited. After an initial screening visit to verify eligibility, all participants will undergo a two-day DBPCFC. Briefly, qualifying participants will be fed increasing amounts of peanut masked in a food matrix. On a different day, the participant will be fed the same amount of the food matrix without any peanut. Overall, the study will require three visits by participants: a screening day to determine if the prospective participants meet eligibility criteria, and two days for the DBPCFC.
Study Procedures
Screening Visit
Prospective participants will come to the Allergy Clinic at the McMaster University Medical Centre for a screening visit up to 6 months prior to the DBPCFC in order to confirm study eligibility. The informed consent form will be reviewed and signed at this time. The allergic status of these prospective participants will be characterized by patient history, skin prick test (SPT), and peanut-specific IgE, so that they can be related to the overall allergic population. Relevant history (all reactions related to peanut and any other foods, other allergic co-morbidities, other medical conditions, medications, family history, etc.) will be recorded. A physical examination will be performed including skin prick tests to peanut and the routine inhalant allergen panel. Blood work will be done as a baseline measure and analyzed as described below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adults between 7-65 years of age.
- •Demonstrated history of peanut allergy based on medical history, positive skin prick test, and peanut-specific IgE CAP-FEIA test. Participants will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes of the ingestion of peanut, the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control, and a positive in vitro peanut-specific IgE (CAP-FEIA) test value >0.35 IU/mL.
- •Ability to discontinue all prescribed and over the counter allergy-related medications for suitable withdrawal periods before starting the challenge trial. See Appendix I for specifications.
排除标准
- •Previous desensitization treatment to peanut
- •Allergies to any component of the oral challenge matrix
- •Unstable allergic conditions such as uncontrolled asthma or chronic urticaria
- •Any clinically significant disease/chronic medical condition which may interfere with study evaluations
结局指标
主要结局
Peanut threshold dose
时间窗: 30 minutes
次要结局
未报告次要终点