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

Graft Vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143501
• Other study ID #: Pre-Post Allo-HSCT Monitoring
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yang Xu, M.D
• Phone: +86 521 67780322
• Email: yangxu[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft Vs Host Disease

Intervention

Diagnostic Test:
• Blood Sample
6 ml blood (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
• Stool Sample
pea-sized amount (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)
• Urine Sample
8 ml (collection occurs once pre-transplantation and at three designated follow-up time points post-transplantation)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Complications	Recording and monitoring the occurrence of complications such as infection, GVHD, etc., documenting their onset time, type, severity, and management.	2 years
Primary	Relapse	Documenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.	2 years
Primary	Overall Survival	OS will be assessed from the first day of stem cells infused to death or last follow-up.	2 years
Secondary	Immune Function	Incidence of neutrophil recovery; Incidence of lymphocyte and monocyte subset recovery	Measured 3 months after stem cells infused