The Microbiota in Kidney Donation and Transplantation
NCT04388930 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130
Last updated 2023-12-14
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.
Conditions
- Kidney Diseases
- Kidney Transplant Failure and Rejection
- Urinary Tract Infections
Interventions
- OTHER
-
Pre-operative assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing
- OTHER
-
Post-operative day 3 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing.
- OTHER
-
Post-operative week 4-6 assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing.
- OTHER
-
Post-operative 3 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing.
- OTHER
-
Pre-operative 6 month assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing.
- OTHER
-
Post-operative month 12 recipient assessment - blood, urine, & faecal sample
Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature. Urine and faecal samples for 16S rRNA gene sequencing.
Sponsors & Collaborators
-
University College, London
collaborator OTHER -
Royal Free Hospital NHS Foundation Trust
lead OTHER
Principal Investigators
-
Research and Development Manager · Sponsor GmbH
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-06-01
Countries
- United Kingdom
Study Locations
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