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Clinical Trials/NCT04281797
NCT04281797
Unknown
Not Applicable

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

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology1 site in 1 country90 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transplantation Infection
Sponsor
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Enrollment
90
Locations
1
Primary Endpoint
Gut microbiome composition
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Responsible Party
Principal Investigator
Principal Investigator

Ihar Iskrou

Head of Cell Transplants Division

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Gut microbiome composition

Time Frame: 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 Outcomes

  • Organ or tissue rejection(2 years post-transplant)
  • Infectious complications after transplantation(2 years post-transplant)

Study Sites (1)

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