Influence of the Intestinal Microbiota on the Clinical Course of Renal Transplantation

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Apr 30, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how the bacteria in our intestines, known as the intestinal microbiota, might affect the recovery of patients who receive kidney transplants. Researchers want to see if keeping a healthy balance of these bacteria can help reduce common issues after transplantation, such as diarrhea, urinary tract infections, and kidney rejection. To find this out, 50 patients who have received a kidney from a deceased donor will be divided into two groups. One group will receive a treatment known as autologous fecal matter transfer, which involves using their own stool to support their gut health, while the other group will continue with their standard post-transplant care without this additional treatment.

To participate in this study, patients must be over 18 years old, have received a kidney from a deceased donor, and have low immunological risk, meaning they are less likely to have a reaction to the new kidney. Patients with certain intestinal diseases or who are at higher risk for complications will not be eligible. Throughout the trial, participants in the treatment group will have regular check-ups to monitor their health and any side effects from the treatment, while the control group will receive standard care. This research aims to better understand the role of gut health in kidney transplant success, potentially leading to improved care for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Recipients of deceased donor kidney transplantation over 18 years of age, able to understand the informed consent form and who have agreed to participate in the study. Only patients with low immunological risk, whose induction for kidney transplantation was performed with basiliximab will be included, regardless of the maintenance immunosuppression combination
• Exclusion Criteria:
• • Recipients of deceased donor kidney transplant with high immunological risk (within the PATHI kidney transplant program).
• • Kidney transplant recipients receiving pretransplant induction with thymoglobulin or polyclonal lymphocyte antiglobulin agents.
• • Living donor kidney transplant recipients.
• • Patients with a history of intestinal pathology such as: ulcerative colitis, Crohn's disease or malabsorptive syndrome or irritable colon prior to their inclusion in the kidney transplant waiting list.
• • Patients with dysphagia, history of aspiration pneumonia or neutropenia prior to transplantation.
• • Patients who, even if they meet the inclusion criteria, upon analysis of pretransplant stool, are found to be carriers of enterotoxigenic or potentially pathogenic strains such as Clostridioides difficile, or multiresistant bacteria (BLEE and/or carbapenemase-producing).