Longitudinal Development of Intestinal Microbiome in IL10RA-deficient Patients After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Escherichia - Shigella
研究概览
简要总结
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.
详细描述
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
- 1 Day 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IL10RA gene mutations;
- •Eligible for hematopoietic stem cell transplantation.
排除标准
- •Unwilling to participate.
结局指标
主要结局
Escherichia - Shigella
时间窗: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the genus level
relative abundance of Firmicutes
时间窗: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the phylum level
Shannon indices
时间窗: 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
Simpson indices
时间窗: 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
relative abundance of Proteobacteria
时间窗: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the phylum level
Clostridium sensus_stricto_1
时间窗: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the genus level
次要结局
- chimerism(during the hospitalization of each eligible patient, an average of 90 days per patient)
- Sobs indices(during the hospitalization of each eligible patient, an average of 90 days per patient)
- platelet count(during the hospitalization of each eligible patient, an average of 90 days per patient)
- Chao1 estimator(during the hospitalization of each eligible patient, an average of 90 days per patient)
- manifestation of graft-versus-host disease(during the hospitalization of each eligible patient, an average of 90 days per patient)
- neutrophil cell count(during the hospitalization of each eligible patient, an average of 90 days per patient)
研究者
Ying HUANG
The director of gastroenterology of Children's Hospital of Fudan University
Children's Hospital of Fudan University