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Changes in the Microbiome Associated With Transplantation

Changes in the Microbiome Associated With Transplantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04280627
Enrollment
300
Registered
2020-02-21
Start date
2019-05-24
Completion date
2025-12-31
Last updated
2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

Keywords

microbiome

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.

Interventions

OTHERSample 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.

Sponsors

University of Manchester
CollaboratorOTHER
Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Microbiome following transplantation3 yearsThe 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

Countries

United Kingdom

Contacts

Primary ContactTitus Augustine, FRCP
titus.augustine@mft.nhs.uk0161 2763647
Backup ContactAngela Dr Summers, PhD
angela.summers@mft.nhs.uk01617012066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026