Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

NCT04281797 | Unknown DMC

• 1 other identifier: Microbiome Minsk_1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Microbiome; Gut microbiome; Stem cell transplantation; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Gut microbiome composition

  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 Outcomes (2)

• Infectious complications after transplantation

  2 years post-transplant

• Organ or tissue rejection

  2 years post-transplant

Study Arms (4)

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

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

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

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

Interventions

Intestinal microbiome new generation sequencing DIAGNOSTIC_TEST

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

HSCT-recipients; Kidney transplant recipients; Liver transplant recipients; MSCT-recipients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology: lead

Study Sites (1)

Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Minsk, 220116, Belarus

Location

Related Publications (4)

• 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.

  PMID: 31976518 BACKGROUND

• 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.

  PMID: 29755707 BACKGROUND

• 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.

  PMID: 29380038 BACKGROUND

• 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

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples. Microbial purified PCR-products.

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor Stoma, MD, PhD

  Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cell Transplants Division

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)