Changes in the Microbiome Associated With Transplantation

NHS Foundation Trust

Status: Enrolling

Conditions: Microbiota

Treatments: Other: Sample Collection

Study type: Observational

Funder types: Other

Identifiers

NCT04280627

B00150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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