Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intestinal Microbiome Composition Dynamics Over the Course of Kidney Transplantation, Liver Transplantation, Allogeneic Hematopoietic Stem Cells and Mesenchymal Stem Cells Transplantation

Conditions
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Transplantation Infection, Kidney Transplant; Complications, Stem Cell Transplant Complications, Liver Transplant; Complications, Microbial Colonization

Intervention / Treatment
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* Diagnostic Test: Intestinal microbiome new generation sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Be willing and able to provide written informed consent for the study. Exclusion Criteria: Patients were excluded from the study if their first sample was not collected prior to the start of transplantation procedure. Samples were excluded from the analysis if they were not aliquoted and stored frozen within 24 hours of collection.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant recipients<br>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<br>* Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.<br>|
| HSCT-recipients<br>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<br>* Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.<br>|
| MSCT-recipients<br>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<br>* Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.<br>|
| Liver transplant recipients<br>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<br>* Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome composition | Dynamics of gut microbiome composition over the course of transplantation (Shannon diversity index, Simpson index, abundance of main taxonomic phyla) | 1 month post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications after transplantation | Incidence of infectious complications | 2 years post-transplant | 
| Organ or tissue rejection | Incidence of organ or tissue rejection | 2 years post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Gut microbiome, Stem cell transplantation, Kidney transplantation