The Microbiota in Kidney Donation and Transplantation

Last updated: December 13, 2023
Sponsor: Royal Free Hospital NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Treatment

Post-operative 3 month assessment - blood, urine, & faecal sample

Post-operative day 3 assessment - blood, urine, & faecal sample

Post-operative week 4-6 assessment - blood, urine, & faecal sample

Clinical Study ID

NCT04388930
125570
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All adult (≥18 years old) undergoing living donor nephrectomy or kidneytransplantation. Patients willing to provide samples including Urine, Blood, Faecalsamples.
  1. Participant able to give Informed Consent
  2. All patients will be at least 18 years old
  3. Patients will either be a live renal transplant donor or a renal transplantrecipient on the waiting list to have or will have had an ABO-blood groupcompatible renal transplant.
  4. Patients attending hospital clinics at participating centre for routine clinicalfollow -up.
  5. Patients willing to comply with study procedures and willing to provide blood,faecal and urine samples.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 130
Treatment Group(s): 6
Primary Treatment: Post-operative 3 month assessment - blood, urine, & faecal sample
Phase:
Study Start date:
March 01, 2020
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Royal Free London NHS Trust

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

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