The Skin Microbiome in Graft Versus Host Disease Dynamics of the Skin-microbiota After Allogeneic Stem Cell Transplantation - a Predictive Marker for Graft Versus Host Disease?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
研究概览
简要总结
Based on the evidence on the impact of the intestinal microbiome on the Graft Versus Host Disease (GVHD) after allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), it is hypothesized that the skin-microbiome may play a role in cutaneous GVHD as well. Therefore, this study aims at investigating the skin-microbiota of patients with GVHD after allo-HSCT and of patients without GVHD after allo-HSCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing allo-HSCT at the University Hospital Basel
排除标准
- •missing ability to judge
- •illiteracy or lack of German, French or English language
结局指标
主要结局
Determination of the bacterial microbiome of patients with GVHD after allo-HSCT vs. patients without GVHD after allo-HSCT
时间窗: at week 52 after transplantation
After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome
Change in skin-microbiota in lesional vs. non-lesional skin of patients with GVHD
时间窗: before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation
After lysis of the microbiota, the DNA is extracted for phylogenetic 16S ribosomal RNA gene sequencing (standard illumina protocol), which is considered the current gold standard to determine the bacterial microbiome
次要结局
- Change in Worst Itch Numerical Rating Scale (WINRS)(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change of the skin-microbiota in correlation with the frequency and type of posttransplant infections (e.g. episodes of bacteraemia).(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change in inter-individual skin-microbiota in allo-HSCT patients(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change in intra-individual skin-microbiota in allo-HSCT patients(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change of the composition of skin-microbiota in correlation with the severity of GVHD(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change in Dermatology Life Quality Index (DLQI)(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change in Eppendorf Itch Questionnaire (EIQ)(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)
- Change in Hospital Anxiety and Depression Scale (HADS)(before transplantation and at week 4, week 12, week 24, week 36 and at week 52 after transplantation)