Changes in the Microbiome Associated With Transplantation

Recruiting

• Conditions: Microbiota

• Registration Number: NCT04280627
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2019-05-24
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the Microbiome following transplantation	3 years	The tissue samples will be examined to identify any microbial organisms. This process will involve cell identification and quantification using standard biological markers to identify cell types and numbers

Trial Locations

Locations (1)

Manchester University NHS Foundationn Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom