Changes in the Microbiome Associated With Transplantation
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 16, 2023
August 1, 2023
6.6 years
February 20, 2020
August 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
Kidney and Transplant Recipients
You may qualify if:
- 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
You may not qualify if:
- Outside of stated age range.
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester University NHS Foundationn Trust
Manchester, Greater Manchester, M13 9WL, United Kingdom
Biospecimen
This study will involve the collection of oral swabs, saliva, urine and faeces samples, blood and skin scrapings from 50 patients (phase 1) and up to 300 patients (phase 2) before (day of arrival in hospital day 0 and after kidney and pancreas transplantation day 1, week 1, 3, 6,12 months. In addition duodenal fluid from the donor duodenum which is opened at the time of pancreas transplantation will also be taken in theatre for analysis. Similar samples will be obtained from deceased multi-organ donors who have consent for research. Similar samples will also be taken from living kidney donors
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Titus Augustine, FRCP
Consultant Transplant Surgeon
- PRINCIPAL INVESTIGATOR
Oana Piscoran, MD
Clinical Research Fellow
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 21, 2020
Study Start
May 24, 2019
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share