Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

August 28, 2022 updated by: Ihar Iskrou, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220116
        • Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruitment will include both patients with planned transplantations as well as recipients in urgent need of transplantation. The study coordinator may identify potential participants via direct referral from a treating physician, review of transplant lists and schedules.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kidney transplant recipients
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
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
HSCT-recipients
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
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
MSCT-recipients
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
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
Liver transplant recipients
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
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month post-transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Investigators

  • Principal Investigator: Igor Stoma, MD, PhD, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microbiome Minsk_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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