Changes in the Microbiome Associated With Transplantation

Microbiota Clinical Trial

Official title:

Changes in the Microbiome Associated With Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280627
• Other study ID #: B00150
• Status: Recruiting
• Start date: May 24, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Titus Augustine, FRCP
• Phone: 0161 2763647
• Email: titus.augustine[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundationn Trust	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Microbiome following transplantation	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	3 years