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Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

NCT ID: NCT04281797

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intestinal microbiome new generation sequencing

Intervention Type DIAGNOSTIC_TEST

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.

Intestinal microbiome new generation sequencing

Intervention Type DIAGNOSTIC_TEST

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.

Intestinal microbiome new generation sequencing

Intervention Type DIAGNOSTIC_TEST

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.

Intestinal microbiome new generation sequencing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Intestinal microbiome new generation sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ihar Iskrou

Head of Cell Transplants Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Igor Stoma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Locations

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Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Minsk, , Belarus

Site Status

Countries

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Belarus

References

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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.

Reference Type BACKGROUND
PMID: 31976518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29755707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29380038 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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Microbiome Minsk_1

Identifier Type: -

Identifier Source: org_study_id

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