Transplantation InfectionNCT04281797
Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients
An observational study of Transplantation Infection and Kidney Transplant; Complications, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplantation Infection, Kidney Transplant; Complications, Stem Cell Transplant Complications
- What is being tested?
- Intestinal microbiome new generation sequencing
- How many people
- 90 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Minsk, 220116
About this study
Official title: 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.
Read the 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.
- Conditions
- Transplantation Infection, Kidney Transplant; Complications, Stem Cell Transplant Complications, Liver Transplant; Complications, Microbial Colonization
- Being tested
- Intestinal microbiome new generation sequencing
- Keywords
- Microbiome, Gut microbiome, Stem cell transplantation, Kidney transplantation
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal microbiome new generation sequencingDiagnostic test
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intestinal microbiome new generation sequencing | |
| 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. Receives: Diagnostic Test: Intestinal microbiome new generation sequencing | |
| 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. Receives: Diagnostic Test: Intestinal microbiome new generation sequencing | |
| 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. Receives: Diagnostic Test: Intestinal microbiome new generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition
Dynamics of gut microbiome composition over the course of transplantation (Shannon diversity index, Simpson index, abundance of main taxonomic phyla)
Measured: 1 month post-transplant
Secondary outcomes (2)
Infectious complications after transplantation
Incidence of infectious complications
Measured: 2 years post-transplant
Organ or tissue rejection
Incidence of organ or tissue rejection
Measured: 2 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ihar Iskrou, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Investigators
- Igor Stoma, MD, PhD, Principal investigator, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281797
- Sponsor's protocol ID
- Microbiome Minsk_1
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31976518Stoma 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.
PubMed 29755707Stoma 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.
PubMed 29380038Igor 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 at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome Composition Dynamics Over the Course of Kidney Transplantation, Liver Transplantation, Allogeneic Hematopoietic Stem Cells and Mesenchymal Stem Cells Transplantation
- ClinicalTrials.gov ID
- NCT04281797
- Acronym / sponsor ID
- Microbiome Minsk_1
- Conditions
- Transplantation Infection, Kidney Transplant; Complications, Stem Cell Transplant Complications, Liver Transplant; Complications, Microbial Colonization
- Keywords
- Microbiome, Gut microbiome, Stem cell transplantation, Kidney transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and HematologyOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | Diagnostic Test: Intestinal microbiome new generation sequencingPatients received kidney transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
| HSCT-recipients | – | Diagnostic Test: Intestinal microbiome new generation sequencingPatients 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. |
| MSCT-recipients | – | Diagnostic Test: Intestinal microbiome new generation sequencingPatients 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. |
| Liver transplant recipients | – | Diagnostic Test: Intestinal microbiome new generation sequencingPatients received liver transplantation, with a baseline pre-transplant fecal sample and post-transplant samples collected. Standard transplantation procedures and precautions are being performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal microbiome new generation sequencingFecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed. | Diagnostic test | HSCT-recipients, Kidney transplant recipients, Liver transplant recipients, MSCT-recipients |
Primary outcome
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)
2 secondary outcomes
Infectious complications after transplantation
Time frame: 2 years post-transplant
Organ or tissue rejection
Time frame: 2 years post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Background: PubMed 31976518Stoma 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.
- Background: PubMed 29755707Stoma 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.
- Background: PubMed 29380038Stoma 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.
- Results publicationIgor 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Stoma, MD, PhD principal investigator
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation Infection and Kidney Transplant; Complications, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome composition (time frame: 1 month post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281797, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.