Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04281797
• Other study ID #: Microbiome Minsk_1
• Status: Enrolling by invitation
• Start date: January 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Kidney Transplant; Complications
• Liver Transplant; Complications
• Microbial Colonization
• Stem Cell Transplant Complications
• Transplantation Infection

Intervention

Diagnostic Test:
• Intestinal microbiome new generation sequencing
Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.

Locations

Country	Name	City	State
Belarus	Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology

Country where clinical trial is conducted

Belarus, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infectious complications after transplantation	Incidence of infectious complications	2 years post-transplant
Secondary	Organ or tissue rejection	Incidence of organ or tissue rejection	2 years post-transplant