Changes in the Microbiome Associated With Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-24

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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