Understanding gut health in patients after stem cell transplants
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
This study is trying to understand how gut health affects patients after stem cell transplants and if it plays a role in developing complications like acute graft-versus-host disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06143501 on ClinicalTrials.gov |
What this trial studies
This observational research project investigates the role of gut immunity in the development of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study will analyze samples from 200 allo-HSCT patients and 50 healthy volunteers to explore changes in intestinal microbiota, metabolites, and immune cell metabolism. Using advanced techniques such as metagenomics and single-cell sequencing, the research aims to uncover correlations between these factors and post-transplant complications. The findings are expected to enhance understanding of gut health's impact on transplant outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with hematologic disorders who are scheduled to undergo allo-HSCT.
Not a fit: Patients with confirmed intestinal infections, autoimmune diseases, or those not in complete remission prior to transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for managing complications in allo-HSCT patients.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated the importance of gut microbiota in transplant outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yang Xu, M.D
- Email: yangxu@suda.edu.cn
- Phone: +86 521 67780322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.