Microbiome Alterations in IL10RA-deficient Patients After HSCT
2020年8月10日 更新者：Ying HUANG、Children's Hospital of Fudan University
Longitudinal Development of Intestinal Microbiome in IL10RA-deficient Patients After Hematopoietic Stem Cell Transplantation
To elucidate the longitudinal development of intestinal microbiota in patients with IL10RA deficiency after hematopoietic stem cell transplantation (HSCT).
The investigators planned to collect fecal samples from IL10RA-deficient patients who received HSCT.
Samples were collected more than once every three days after engraftment in lamina flow ward and at least once a week before discharge.
Microbial DNA was extracted from the fecal samples.
And all analysis was based on the next generation sequencing data.
研究概览
详细说明
Hematopoietic stem cell transplantation is considered the only curative therapy for patients with interleukin-10 receptor-A(IL10RA) deficiency.
The investigators aimed to collect the fecal samples of these patients throughout the conditioning, transplantation until discharge, providing a dense insight into the longitudinal development of intestinal microbiota.
研究类型
观察性的
注册 (实际的)
13
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、201102
- Children's Hospital of Fudan University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1天 至 6年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients who were diagnosed with IL10RA deficiency and who received the hematopoietic stem cell transplantation in a tertiary hospital were enrolled.
描述
Inclusion Criteria:
- IL10RA gene mutations;
- Eligible for hematopoietic stem cell transplantation.
Exclusion Criteria:
- Unwilling to participate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
HSCT cohort
IL10RA-deficient patients who received hematopoietic stem cell transplantation
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Shannon indices
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
Shannon index is a popular diversity index in the ecological literature; minimum score is zero, higher values represent a better outcome
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Simpson indices
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
Simpson index in ecology is to measure the degree of concentration when individuals are classified into types; scale ranges [0,1]; lower values represent a better outcome
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
relative abundance of Proteobacteria
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the microbiome at the phylum level
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
relative abundance of Firmicutes
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the microbiome at the phylum level
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Clostridium sensus_stricto_1
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the microbiome at the genus level
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Escherichia - Shigella
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the microbiome at the genus level
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
chimerism
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
The level of chimerism of each patient will be reported as percentages [0,100%]
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
manifestation of graft-versus-host disease
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the graft-versus-host disease happened to each patient
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Sobs indices
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the the observed richness of each sample
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Chao1 estimator
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the operational taxonomic unit(OTU) numbers of each sample
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
neutrophil cell count
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
blood test results
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
platelet count
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
blood test results
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
relative abundance of Clostridiales
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
describe the microbiome at the order level
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Shannoneven indices
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
measure the community evenness, scale ranges [0,1]; higher values represent a better outcome
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
|
Simpsoneven indices
大体时间：during the hospitalization of each eligible patient, an average of 90 days per patient
|
measure community evenness, scale ranges [0,1]; higher values represent a better outcome
|
during the hospitalization of each eligible patient, an average of 90 days per patient
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ying Huang, MD、Children's Hospital of Fudan University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月1日
初级完成 (实际的)
2020年2月28日
研究完成 (实际的)
2020年2月28日
研究注册日期
首次提交
2018年11月19日
首先提交符合 QC 标准的
2018年11月21日
首次发布 (实际的)
2018年11月26日
研究记录更新
最后更新发布 (实际的)
2020年8月12日
上次提交的符合 QC 标准的更新
2020年8月10日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.