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Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT

Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06143501
Enrollment
250
Registered
2023-11-22
Start date
2020-09-01
Completion date
2024-12-31
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Vs Host Disease

Keywords

Allo-HSCT, Intestinal Microbiota, Metabolites, Immunity

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.

Interventions

DIAGNOSTIC_TESTBlood Sample

6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)

DIAGNOSTIC_TESTStool Sample

pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)

DIAGNOSTIC_TESTUrine Sample

8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)

Sponsors

The First Affiliated Hospital of Soochow University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Patients with hematologic disorders undergoing allo-HSCT.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Complications2 yearsRecording and monitoring the occurrence of complications such as infection, GVHD, etc., documenting their onset time, type, severity, and management.
Relapse2 yearsDocumenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.
Overall Survival2 yearsOS will be assessed from the first day of stem cells infused to death or last follow-up.

Secondary

MeasureTime frameDescription
Immune FunctionMeasured 3 months after stem cells infusedIncidence of neutrophil recovery; Incidence of lymphocyte and monocyte subset recovery

Countries

China

Contacts

Primary ContactYang Xu, M.D
yangxu@suda.edu.cn+86 521 67780322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026