The Microbiota in Kidney Donation and Transplantation

NCT04388930 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2023-12-14

No results posted yet for this 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.

Conditions

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388930 on ClinicalTrials.gov