Clinical trial NCT04281797: Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients
Official title: Intestinal Microbiome Composition Dynamics Over the Course of Kidney Transplantation, Liver Transplantation, Allogeneic Hematopoietic Stem Cells and Mesenchymal Stem Cells Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplantation Infection
Kidney Transplant; Complications
Stem Cell Transplant Complications
Liver Transplant; Complications
Microbial Colonization
Keywords: Microbiome
Gut microbiome
Stem cell transplantation
Kidney transplantation
Lead sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Sponsor class: OTHER_GOV
First posted: 2020-02-24
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiome composition
timeFrame: 1 month post-transplant
Secondary outcomes:
measure: Infectious complications after transplantation
timeFrame: 2 years post-transplant
measure: Organ or tissue rejection
timeFrame: 2 years post-transplant
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
Study officials:
affiliation: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
name: Igor Stoma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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