Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Relapse
研究概览
简要总结
This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Addressing the current gaps in understanding the involvement of intestinal microbiota, metabolites, and cellular metabolism in clinical aGVHD, the study involves comprehensive analyses on 200 allo-HSCT patients and 50 healthy volunteers. By scrutinizing changes in gut microbiota, metabolites, and immune cell metabolism, the research aims to shed light on their roles in allo-HSCT and their correlation with post-transplant complications. The findings are poised to offer crucial insights for diagnosing and prognosticating complications following transplantation.
详细描述
The intestinal immune system plays a pivotal role in the onset, progression, and evolution of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the precise contributions and mechanisms underlying the involvement of intestinal microbiota, metabolites, and cellular metabolism in immune regulation during clinical aGVHD remain unclear.
This research initiative aims to collect peripheral blood, fecal, and urine samples from 200 patients before and after transplantation as well as 50 healthy volunteers. Comprehensive analyses, including metagenomics, 16S rRNA sequencing, transcriptomics, metabolomics, single-cell sequencing, as well as assessments of immune cell function and inflammatory cytokines, will be conducted. Additionally, longitudinal follow-up observations will be performed to monitor post-transplant complications, relapse and immune reconstitution.
By investigating the dynamics of gut microbiota, metabolites, and cellular metabolism and analyzing their correlation with changes in immune responses, this study seeks to elucidate the roles of intestinal microbiota, metabolites, and immune cell metabolism in the context of allo-HSCT. The findings are anticipated to provide insights into the correlation between these factors and outcomes of allo-HSCT patients, contributing valuable evidence for the diagnosis and prognosis assessment of complications following transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with hematologic disorders undergoing allo-HSCT.
排除标准
- •Patients with confirmed pathogenic intestinal infections and severe systemic infections at the time of sampling.
- •Diagnosis of autoimmune diseases, metabolic disorders, and chronic gastrointestinal diseases.
- •Pre-transplant diseases not in complete remission.
- •Post-transplant hematopoietic engraftment failure or pre-engraftment mortality.
结局指标
主要结局
Relapse
时间窗: 2 years
Documenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.
Overall Survival
时间窗: 2 years
OS will be assessed from the first day of stem cells infused to death or last follow-up.
Incidence of Complications
时间窗: 2 years
Recording and monitoring the occurrence of complications such as infection, GVHD, etc., documenting their onset time, type, severity, and management.
次要结局
- Immune Function(Measured 3 months after stem cells infused)