Walnut Oral Immunotherapy for Tree Nut Allergy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut.
研究概览
简要总结
The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.
详细描述
Tree nut
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (> 3mm) or serologic evidence of allergic sensitization (defined as specific IgE > 0.35 kU/L) to walnut and at least one other tree nut.
- •A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut.
- •Written informed consent from participant and/or parent/guardian
- •Written assent from all subjects as appropriate
- •All females of child bearing age must be using appropriate birth control
排除标准
- •History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
- •Known allergy to oat
- •Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
- •Poor control or persistent activation of atopic dermatitis
- •Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
- •Participation in any interventional study for food allergy in the past 6 months
- •Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
- •Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2) or poorly controlled mild or moderate asthma
- •Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
- •Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
- •Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- •Pregnancy or lactation
研究组 & 干预措施
Walnut protein flour
Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.
干预措施: Walnut Protein Flour (Drug)
Oat flour
Oat flour administered in identical increasing amounts as the active walnut protein flour.
干预措施: Oat flour (Drug)
结局指标
主要结局
Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut.
时间窗: 38 weeks
The determination of the effectiveness of WOIT in inducing clinical desensitization to a second tree nut to which the subject is allergic when compared to placebo. This will be measured by the change in the amount of tree nut the subject can consume during their food challenge at 38 weeks compared to their consumption during the baseline challenge at study entry.
次要结局
- Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study(38 weeks)
- The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut.(38 weeks)
- The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut.(36 months)
研究者
Wesley Burks, MD
Professor
University of North Carolina, Chapel Hill