NCT05521711招募中不适用
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Eliciting dose thresholds to food challenge
研究概览
简要总结
Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
排除标准
- •History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
- •Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
- •Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
- •Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
- •Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
- •Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator
结局指标
主要结局
Eliciting dose thresholds to food challenge
时间窗: 1 year
次要结局
- Quality of life(1 Year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Boiled Tree Nut for Oral Immunotherapy in Food-allergic ChildrenFood Allergy in ChildrenFood AllergyNCT06467994Chinese University of Hong Kong75
已完成
不适用
Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent Marijuana AbuseCannabis Use Disorder, MildCannabis Use Disorder, ModerateNCT04923230Oregon Research Institute120
已完成
1 期
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc DiseaseIntervertebral Disc DiseaseNCT01513694Red de Terapia Celular15
撤回
3 期
Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)COVID-19NCT05387317Murdoch Childrens Research Institute
招募中
不适用
Efficacy of Cashew Nut Protein ImmunotherapyFood AllergyNCT06328504Medical University of Warsaw39