Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients
Study Details
Study Description
Brief Summary
This is a pilot study designed to investigate the alterations in the gut microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic hematopoietic stem cells and mesenchymal stem cells transplantation in association with the clinical outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is a pilot study designed to investigate the dynamic changes in the intestinal microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic HSCs and mesenchymal stem cells transplantation. Four patient cohorts will be followed. Cohort A: patients receiving kidney transplantation. Cohort B: patients receiving hematopoietic stem cells transplantation. Cohort C: patients receiving mesenchymal stem cells transplantation. Cohort D: patients receiving liver transplantation. Included participants are defined as patients with at least three analyzable stool samples including a baseline sample before the transplantation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kidney transplant recipients Patients received kidney transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
Diagnostic Test: Intestinal microbiome new generation sequencing
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
|
| HSCT-recipients Patients received hematopoietic stem cells transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
Diagnostic Test: Intestinal microbiome new generation sequencing
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
|
| MSCT-recipients Patients received mesenchymal stem cells transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
Diagnostic Test: Intestinal microbiome new generation sequencing
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
|
| Liver transplant recipients Patients received liver transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
Diagnostic Test: Intestinal microbiome new generation sequencing
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
|
Outcome Measures
Primary Outcome Measures
- Gut microbiome composition [1 month post-transplant]
Dynamics of gut microbiome composition over the course of transplantation (Shannon diversity index, Simpson index, abundance of main taxonomic phyla)
Secondary Outcome Measures
- Infectious complications after transplantation [2 years post-transplant]
Incidence of infectious complications
- Organ or tissue rejection [2 years post-transplant]
Incidence of organ or tissue rejection
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants enrolled into kidney transplantation or HSCs transplantation or MSCs transplantation or liver transplantation programs with fecal samples collected over the course of their initial transplant hospitalization.
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Be willing and able to provide written informed consent for the study.
Exclusion Criteria:
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Patients were excluded from the study if their first sample was not collected prior to the start of transplantation procedure.
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Samples were excluded from the analysis if they were not aliquoted and stored frozen within 24 hours of collection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology | Minsk | Belarus | 220116 |
Sponsors and Collaborators
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Investigators
- Principal Investigator: Igor Stoma, MD, PhD, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Study Documents (Full-Text)
None provided.More Information
Publications
- Stoma I, Karpov I, Iskrov I, Krivenko S, Uss A, Vlasenkova S, Lendina I, Cherniak V, Suvorov D. Decolonization of Intestinal Carriage of MDR/XDR Gram-Negative Bacteria with Oral Colistin in Patients with Hematological Malignancies: Results of a Randomized Controlled Trial. Mediterr J Hematol Infect Dis. 2018 May 1;10(1):e2018030. doi: 10.4084/MJHID.2018.030. eCollection 2018.
- Stoma I, Karpov I, Krivenko S, Iskrov I, Milanovich N, Koritko A, Uss A. Mesenchymal stem cells transplantation in hematological patients with acute graft-versus-host disease: characteristics and risk factors for infectious complications. Ann Hematol. 2018 May;97(5):885-891. doi: 10.1007/s00277-018-3250-8. Epub 2018 Jan 29.
- Stoma I, Littmann ER, Peled JU, Giralt S, van den Brink MRM, Pamer EG, Taur Y. Compositional Flux Within the Intestinal Microbiota and Risk for Bloodstream Infection With Gram-negative Bacteria. Clin Infect Dis. 2021 Dec 6;73(11):e4627-e4635. doi: 10.1093/cid/ciaa068.
- Microbiome Minsk_1