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Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04281797
Enrollment
90
Registered
2020-02-24
Start date
2020-01-01
Completion date
2023-06-30
Last updated
2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Microbiome, Gut microbiome, Stem cell transplantation, Kidney transplantation

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.

Interventions

DIAGNOSTIC_TESTIntestinal microbiome new generation sequencing

Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.

Sponsors

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiome composition1 month post-transplantDynamics of gut microbiome composition over the course of transplantation (Shannon diversity index, Simpson index, abundance of main taxonomic phyla)

Secondary

MeasureTime frameDescription
Infectious complications after transplantation2 years post-transplantIncidence of infectious complications
Organ or tissue rejection2 years post-transplantIncidence of organ or tissue rejection

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026