Viewing Study NCT06143501



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Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06143501
Status: RECRUITING
Last Update Posted: 2023-11-22
First Post: 2023-11-16

Brief Title: Alterations in Intestinal Microbiota Metabolites and Immune Cells in Allo-HSCT
Sponsor: The First Affiliated Hospital of Soochow University
Organization: The First Affiliated Hospital of Soochow University

Study Overview

Official Title: Alterations in Intestinal Microbiota Metabolites and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None