NCT04388930

The Microbiota in Kidney Donation and Transplantation

Longitudinal Characterisation of the Host Microbiota After Kidney Donation and Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Royal Free Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2020-05-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: United Kingdom