Studying how organ transplantation affects the microbiome
Changes in the Microbiome Associated With Transplantation
Manchester University NHS Foundation Trust · NCT04280627
This study looks at how organ transplants and the medications that prevent rejection affect the bacteria in the bodies of kidney and pancreas transplant patients over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust (other gov) |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT04280627 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of organ transplantation and immunosuppression on the human microbiome. It will involve collecting various biological samples, including oral swabs, saliva, urine, and blood, from kidney and pancreas transplant recipients at multiple time points over one year. The samples will be analyzed using 16s rRNA gene sequencing to understand how the microbiome changes in response to surgery and medication. The study will recruit participants from both deceased and living donor transplant groups.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are recipients of kidney or pancreas allografts.
Not a fit: Patients outside the age range of 18 to 75 or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how transplantation affects the microbiome, potentially leading to improved patient outcomes and management strategies.
How similar studies have performed: While studies on the microbiome have been conducted, this specific approach focusing on transplantation and immunosuppression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age. * Under 75 years * Participants must be able to receive and understand English verbal and written information regarding the study and give written, informed consent. * Participants will be recipients of pancreas or kidney allografts Exclusion Criteria: * Outside of stated age range. * Unable to give informed consent
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundationn Trust — Manchester, Greater Manchester, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Titus Augustine, FRCP — Consultant Transplant Surgeon
- Study coordinator: Titus Augustine, FRCP
- Email: titus.augustine@mft.nhs.uk
- Phone: 0161 2763647
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.
Conditions: Microbiota, microbiome