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

NCT06143501 | Unknown

• 1 other identifier: Pre-Post Allo-HSCT Monitoring
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Vs Host Disease

Keywords

Allo-HSCT; Intestinal Microbiota; Metabolites; Immunity

Outcome Measures

Primary Outcomes (3)

• 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

• Relapse

  Documenting and monitoring the occurrence of relapse in study subjects, including recording the time of onset, severity, and management.

  2 years

• Overall Survival

  OS will be assessed from the first day of stem cells infused to death or last follow-up.

  2 years

Secondary Outcomes (1)

• Immune Function

  Measured 3 months after stem cells infused

Study Arms (2)

Allo-HSCT Recipients

Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample

Healthy Volunteers

Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample

Interventions

Blood Sample DIAGNOSTIC_TEST

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

Allo-HSCT Recipients; Healthy Volunteers

Stool Sample DIAGNOSTIC_TEST

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

Allo-HSCT Recipients; Healthy Volunteers

Urine Sample DIAGNOSTIC_TEST

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

Allo-HSCT Recipients; Healthy Volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hematological patients will receive allo-HSCT in short time.

You may qualify if:

• Patients with hematologic disorders undergoing allo-HSCT.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yang Xu, M.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Yang Xu, M.D

CONTACT

+86 521 67780322; yangxu@suda.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: September 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)