Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

• Conditions: Transplantation Infection; Kidney Transplant; Complications; Liver Transplant; Complications; Microbial Colonization; Stem Cell Transplant Complications
• Interventions: Diagnostic Test: Intestinal microbiome new generation sequencing

• Registration Number: NCT04281797
• Lead Sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-28
• Last Update Posted: 2022-08-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplant recipients	Intestinal microbiome new generation sequencing	Patients received liver transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed.
Kidney transplant recipients	Intestinal microbiome new generation sequencing	Patients received kidney transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed.
MSCT-recipients	Intestinal microbiome new generation sequencing	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.
HSCT-recipients	Intestinal microbiome new generation sequencing	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Organ or tissue rejection	2 years post-transplant	Incidence of organ or tissue rejection
Infectious complications after transplantation	2 years post-transplant	Incidence of infectious complications

Trial Locations

Locations (1)

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology; 🇧🇾 Minsk, Belarus