Changes in the Microbiome Associated With Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in the Microbiome following transplantation
研究概览
简要总结
To study the effects of organ transplantation and immunosuppression on the human microbiome, and to understand the interlinkage of changes in the microbiome with clinical events surrounding transplantation, and graft and patient clinical outcomes.
详细描述
This study will involve the collection of oral swabs, saliva, urine and rectal swabs, blood and skin scrapings from patients before and after kidney and pancreas transplantation. At Day 0 and day 1, week 1, and at 3, 6, and 12 months.
These samples will be collected longitudinally over a period of one year after transplantation and will be analysed using 16s rRNA gene sequencing in order to capture the dynamics of the microbiome after exposure to surgery, immunosuppression and the specific medication necessary during the process of transplantation.
Two groups of recipients will be recruited, the first one includes kidney and/or pancreas transplant recipients from both deceased and living donors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Under 75 years
- •Participants must be able to receive and understand English verbal and written information regarding the study and give written, informed consent.
- •Participants will be recipients of pancreas or kidney allografts
排除标准
- •Outside of stated age range.
- •Unable to give informed consent
结局指标
主要结局
Changes in the Microbiome following transplantation
时间窗: 3 years
The tissue samples will be examined to identify any microbial organisms. This process will involve cell identification and quantification using standard biological markers to identify cell types and numbers
次要结局
未报告次要终点