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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
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 |
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