Examining the role of gut bacteria in kidney donation and transplantation
Longitudinal Characterisation of the Host Microbiota After Kidney Donation and Transplantation
This study looks at how changes in gut bacteria and their byproducts affect the immune system of people who have received a kidney transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Free Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04388930 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how changes in the urinary and gastrointestinal microbiota, along with their metabolites, influence host immunity following kidney transplantation. Participants will undergo a series of assessments, including the collection of blood, urine, and fecal samples at various stages: pre-operative, post-operative day 3, week 4-6, and 3 months. The goal is to better understand the relationship between microbiota alterations and clinical outcomes in renal transplant patients, an area that has not been extensively studied compared to other organ systems.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are either living kidney donors or recipients on the waiting list for a compatible kidney transplant.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical outcomes for kidney transplant patients by targeting the gastrointestinal microbiota.
How similar studies have performed: While the role of microbiota in other organ systems has been explored, studies specifically focusing on renal transplantation are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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 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.
Where this trial is running
London
- Royal Free London NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Reza Motallebzadeh
- Email: r.motallebzadeh@ucl.ac.uk
- Phone: 020 7794 0500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.