Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.
研究概览
简要总结
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
详细描述
The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 1 and 16 years of age
- •Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
- •A family that will be able to be compliant with all study visits.
排除标准
- •Subjects with a history of severe anaphylaxis to peanut
- •Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) < 80% of predicted, or FEV1/FVC (forced vital capacity) < 75%, with or without controller medications
- •Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
- •Pregnant or lactating
- •Allergy to oat
研究组 & 干预措施
Peanut protein
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
干预措施: Peanut protein (Drug)
结局指标
主要结局
The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.
时间窗: 2 to 5 years
Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.
时间窗: 2 to 5 years
Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
次要结局
- Changes in number of antigen-specific lymphocytes.(2 to 5 years)
- Changes in function of antigen-specific lymphocytes.(2-5 years)
研究者
Wesley Burks, MD
Professor of Pediatrics
University of North Carolina, Chapel Hill