The Microbiota in Kidney Donation and Transplantation

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    130
  • sponsor
    Royal Free Hospital NHS Foundation Trust
Updated on 14 October 2021
diabetes
cardiovascular disease
cancer
kidney transplant
nephrectomy

Summary

The human gastrointestinal tract harbours ~40 trillion microbial cells, far outnumbering the cell number, and therefore the genetic content of its host. How this genetically diverse bacterial (collectively referred as 'microbiota') co-resident modulates host homeostasis is largely unknown. We are increasing gaining a better understanding how the microbes modulate mucosal and systemic metabolic/immune and organ systems including the kidney, heart and the brain. Therapeutic targeting of the gastrointestinal (GI) microbiota may help improve clinical outcomes in conditions as diverse as arthritis, cardiovascular disease, and cancer. In contrast to other organ systems, studies investigating the role of the microbiota in modulating clinical outcomes in renal transplantation lags behind.

The aim of the study is to examine (a) how alterations in the urinary and GI microbiota and associated metabolites impact on host immunity after renal transplantation, and (b) whether such changes are correlated with post-transplant complications, such as rejection, development of de novo donor specific antibodies, metabolic complications (e.g post-transplant diabetes) and infections. Participants will be followed before and up to twelve months post-transplantation, and, longitudinal microbial data will be correlated with in-depth immune phenotyping and clinical end-points to define the impact that changes in urinary and GI microbial ecology have on kidney transplant outcomes.

Details
Condition urinary tract infection (uti), Urinary Tract Infections, nephrologic disease, Recurrent Urinary Tract Infections, Kidney Transplant Failure and Rejection, kidney disorders, Nephropathy, disease, kidney, urinary infection, Kidney Disease (Pediatric), Recurrent Urinary Tract Infection, renal disease, Kidney Disease, kidney disorder, Urinary tract infection, kidney diseases, recurrent utis
Treatment Pre-operative assessment - blood, urine, & faecal sample, Post-operative day 3 assessment - blood, urine, & faecal sample, Post-operative week 4-6 assessment - blood, urine, & faecal sample, Post-operative 3 month assessment - blood, urine, & faecal sample, Pre-operative 6 month assessment - blood, urine, & faecal sample, Post-operative month 12 recipient assessment - blood, urine, & faecal sample
Clinical Study IdentifierNCT04388930
SponsorRoyal Free Hospital NHS Foundation Trust
Last Modified on14 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All adult (18 years old) undergoing living donor nephrectomy or kidney transplantation. Patients willing to provide samples including Urine, Blood, Faecal samples
Participant able to give Informed Consent
All patients will be at least 18 years old
Patients will either be a live renal transplant donor or a renal transplant recipient on the waiting list to have or will have had an ABO-blood group compatible renal transplant
Patients attending hospital clinics at participating centre for routine clinical follow -up
Patients willing to comply with study procedures and willing to provide blood, faecal and urine samples

Exclusion Criteria

Patients under the age of 18 years
Patients unable to give informed consent
Patients not able to comply with study procedures or follow-up visits
Patients that are not a live renal donor or that are not on the waiting list to have or have not had an ABO blood group compatible renal transplant and are not attending hospital outpatient clinics at participating study centres for routine clinical follow-up
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