Alteration of Respiratory Microbiota and Local Immune Response in Common Variable Immunodeficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples
研究概览
简要总结
Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary antibody deficiency diagnosed by their treating physician
- •Controls will not have a diagnosis of immunodeficiency of any sort
- •Male and female patients will be enrolled evenly
排除标准
- •Patients who self identify as pregnant
- •Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically
研究组 & 干预措施
Antibody deficient participants
Provider referred patients that have antibody deficiency.
Controls
Patients without antibody deficiency from the allergy and immunology clinic at Boston Medical Center and from healthy volunteers at the BU School of Medicine.
结局指标
主要结局
Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples
时间窗: 2 years
RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of microbiota constituency.
Feasibility of respiratory sample RNA sequencing (RNAseq) analysis
时间窗: 1 year
Quality control analysis of RNA samples collected from nasopharyngeal swabs for adequacy to perform RNA-seq analysis will be performed. This will be done using the Boston University (BU) Medical Campus RNA core facility bioanalyzer, which will assess for adequate RNA quality and quantity for RNA-seq
Host gene expression analysis by RNA-seq of nasopharyngeal samples
时间窗: 2 years
RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of host gene and pathway expression.
Analysis of saliva sampling
时间窗: 2 years
Saliva samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) and multiplex analysis (Luminex) for levels of antibodies as well as cytokines and other inflammatory proteins.
次要结局
- Altered respiratory microbiota due to primary antibody deficiency(2 years)
- Altered gene expression due to primary antibody deficiency(2 years)