The Microbiota in Kidney Donation and Transplantation

NHS Foundation Trust

Status

Enrolling

Conditions

Urinary Tract Infections

Kidney Diseases

Kidney Transplant Failure and Rejection

Treatments

Other: Pre-operative assessment - blood, urine, & faecal sample

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

Other: Pre-operative 6 month assessment - blood, urine, & faecal sample

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

Other: Post-operative month 12 recipient assessment - blood, urine, & faecal sample

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

Study type

Observational

Funder types

Other

Identifiers

NCT04388930

125570

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All adult (≥18 years old) undergoing living donor nephrectomy or kidney transplantation. Patients willing to provide samples including Urine, Blood, Faecal samples.
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 transplant recipient on the waiting list to have or will have had an ABO-blood group compatible renal transplant.
4. Patients attending hospital clinics at participating centre for routine clinical follow -up.
5. 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.