- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281797
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
-
-
-
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.
|
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.
|
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.
|
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.
|
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.
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
- Stoma I, Littmann ER, Peled JU, Giralt S, van den Brink MRM, Pamer EG, Taur Y. Compositional Flux Within the Intestinal Microbiota and Risk for Bloodstream Infection With Gram-negative Bacteria. Clin Infect Dis. 2021 Dec 6;73(11):e4627-e4635. doi: 10.1093/cid/ciaa068.
- Stoma I, Karpov I, Iskrov I, Krivenko S, Uss A, Vlasenkova S, Lendina I, Cherniak V, Suvorov D. Decolonization of Intestinal Carriage of MDR/XDR Gram-Negative Bacteria with Oral Colistin in Patients with Hematological Malignancies: Results of a Randomized Controlled Trial. Mediterr J Hematol Infect Dis. 2018 May 1;10(1):e2018030. doi: 10.4084/MJHID.2018.030. eCollection 2018.
- Stoma I, Karpov I, Krivenko S, Iskrov I, Milanovich N, Koritko A, Uss A. Mesenchymal stem cells transplantation in hematological patients with acute graft-versus-host disease: characteristics and risk factors for infectious complications. Ann Hematol. 2018 May;97(5):885-891. doi: 10.1007/s00277-018-3250-8. Epub 2018 Jan 29.
- Igor Stoma, Mikhail Uss, Natalia Milanovich, Valentina Stoma, Tatiana Gubanova, Ekaterina Moduleva, Igor Iskrov & Anatoly Uss (2022) Biodiversity screening of gut microbiome during the allogeneic hematopoietic stem cell transplantation: data from the real-life clinical practice, All Life, 15:1, 547-554, DOI: 10.1080/26895293.2022.2074546
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
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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