Examining the link between gut bacteria and chronic graft-versus-host disease after stem cell transplantation

The Association of Microbiota Composition With Chronic Graft Versus Host Disease

This study is trying to see if the types of bacteria in the gut can help identify patients at risk for chronic graft-versus-host disease after they receive a stem cell transplant.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 10 sites (Hangzhou, Zhejiang and 9 other locations)
• Trial ID: NCT05355675 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between microbiota composition and chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). It aims to identify microbiome markers that could help in early detection of patients at high risk for cGVHD. Participants will provide blood and stool samples for analysis, including plasma banking and microbiome studies through DNA/RNA isolation and sequencing. The study is multicenter and nonrandomized, focusing on understanding how gut microbiota may influence post-transplant complications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who are scheduled to undergo allogeneic hematopoietic stem cell transplantation.

Not a fit: Patients outside the age range of 18 to 65 or those not undergoing allo-HSCT will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized interventions that improve treatment outcomes and reduce the incidence of severe cGVHD in patients undergoing stem cell transplantation.

How similar studies have performed: While previous studies have explored the microbiome's role in transplantation outcomes, this specific approach focusing on cGVHD is relatively novel and under-researched.

Eligibility criteria

Inclusion Criteria:

1. aged between 18 years and 65 years
2. patients planned to be treated by allogeneic hematopoietic cell transplantation
3. signed written informed consent

Exclusion Criteria:

patients not-matching inclusion criteria

Where this trial is running

Hangzhou, Zhejiang and 9 other locations

• The first Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
• First Affiliated Hospital of Zhejiang Chinese Medicine University — Hangzhou, Zhejiang, China (RECRUITING)
• Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University — Hangzhou, China (RECRUITING)
• Zhejiang Provincial People's Hospital — Hangzhou, China (RECRUITING)
• Jinhua Hospital of Zhejiang University — Jinhua, China (RECRUITING)
• Ningbo Hospital of Zhejiang University — Ningbo, China (RECRUITING)
• The Affiliated People's Hospital of Ningbo University — Ningbo, China (RECRUITING)
• The Affiliated People's Hospital of Ningbo University — Ningbo, China (RECRUITING)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (RECRUITING)

Study contacts

• Principal investigator: Yi Luo, M.D. — First Affilaated Hospital of Medical School of Zhejiang University
• Study coordinator: Yi Luo, M.D.

Conditions: Hematopoietic Stem Cell Transplantation, Hematologic Malignancy, Chronic Graft-versus-host-disease, Complication, hematopoietic stem cell transplantation, microbiota, metabolomics, chronic graft versus host disease