NCT03942159Unknown不适用
Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- beta-index dynamics
研究概览
简要总结
Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indications to alloHSCT
- •nursing healthy donors 3-55 y.o.
排除标准
- •unable to give samples for the test
- •graft rejection
- •previous HSCT
结局指标
主要结局
beta-index dynamics
时间窗: 60 days after HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
次要结局
- Proportion of patients with microbial domination after HSCT(60 days after HSCT)
- Shannon-index dynamics(60 days after HSCT)
- ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)(60 days after HSCT)
研究者
研究点 (1)
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