NCT04280627

Changes in the Microbiome Associated With Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the effects of organ transplantation and immunosuppression on the human microbiome, and to understand the interlinkage of changes in the microbiome with clinical events surrounding transplantation, and graft and patient clinical outcomes.

Detailed description

This study will involve the collection of oral swabs, saliva, urine and rectal swabs, blood and skin scrapings from patients before and after kidney and pancreas transplantation. At Day 0 and day 1, week 1, and at 3, 6, and 12 months. These samples will be collected longitudinally over a period of one year after transplantation and will be analysed using 16s rRNA gene sequencing in order to capture the dynamics of the microbiome after exposure to surgery, immunosuppression and the specific medication necessary during the process of transplantation. Two groups of recipients will be recruited, the first one includes kidney and/or pancreas transplant recipients from both deceased and living donors.

Conditions

• Microbiota

Interventions

Type	Name	Description
OTHER	Sample Collection	This study will involve the collection of oral swabs, saliva, urine and faeces samples, blood and skin scrapings from patients before and after kidney and pancreas transplantation at day 0, day 1, week 1 and at 3, 6 and 12 months post-transplant.

Timeline

• Start date: 2019-05-24
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-02-21
• Last updated: 2023-08-16

Locations

1 site across 1 country: United Kingdom