Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Status: Invitation-only

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

Treatments: Diagnostic Test: Intestinal microbiome new generation sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT04281797

Microbiome Minsk_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 4 patient groups

Kidney transplant recipients

Description:

Patients received kidney transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed.

Treatment:

Diagnostic Test: Intestinal microbiome new generation sequencing

HSCT-recipients

Description:

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.

Treatment:

Diagnostic Test: Intestinal microbiome new generation sequencing

MSCT-recipients

Description:

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.

Treatment:

Diagnostic Test: Intestinal microbiome new generation sequencing

Liver transplant recipients

Description:

Patients received liver transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed.

Treatment:

Diagnostic Test: Intestinal microbiome new generation sequencing