Luminex-based Assay to Identify Major IgE-binding Episode Among IgE-mediated Wheat-allergic Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major Immunoglobulin (Ig) E-binding epitope on wheat proteins and serum/plasma of patients
研究概览
简要总结
This study will be using Luminex-based peptide assay (LPA) to determine major IgE-binding epitope among wheat allergic children to differentiate clinical phenotype.
详细描述
Luminex-based peptide assay (LPA) is a novel tool using machine learning techniques, developed to predict different degrees of food allergy has been successfully reported among cow's milk protein allergy. This technique provide a more precise and advanced adaptation from microarray-based immunoassay (MIA). Using this technique will aid us for the differentiation of clinical phenotypes of wheat-allergic patients. This study will be the first study to date using this technique aim to determine major IgE-binding epitope among immediated-reaction of wheat allergic children to differentiate clinical phenotypes, and may lead to further study to develop the new therapeutic approach to wheat-allergic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Major Immunoglobulin (Ig) E-binding epitope on wheat proteins and serum/plasma of patients
时间窗: 48 months
For Luminex data, the binding intensity of antibody to epitope specific beads was calculated from the florescence signal of each bead. An index score of binding intensity was generated from the log2 transformation of the signal-to-background ratio and each peptide element, which was close to a normal distribution. A plate effect was observed and adjusted for using linear models. Antibody binding intensities (Luminex) from different groups were compared. To assess the changes in epitope-binding profiles, a linear model was used with group as a factor. Comparisons of interests were tested using t tests and resultant P-values were adjusted for multiple hypotheses using the Benjamini-Hochberg approach, which controls the false discovery rate (FDR) across epitopes. Epitopes were defined as differentially binding epitopes (DBE) if the FDR \< 0.05 and fold changes (FCH) \> 1.5.
次要结局
- Predict different severity of wheat hypersensitivity reaction(48 months)