- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280627
Changes in the Microbiome Associated With Transplantation
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Titus Augustine, FRCP
- Phone Number: 63647 0161 2763647
- Email: titus.augustine@mft.nhs.uk
Study Contact Backup
- Name: Angela Dr Summers, PhD
- Phone Number: 12066 01617012066
- Email: angela.summers@mft.nhs.uk
Study Locations
-
-
Greater Manchester
-
Manchester, Greater Manchester, United Kingdom, M13 9WL
- Recruiting
- Manchester University NHS Foundationn Trust
-
Contact:
- Titus Augustine, FRCP
- Phone Number: 0161 2763647
- Email: titus.augustine@mft.nhs.uk
-
Contact:
- Angela Summers, PhD
- Phone Number: 12066 01617012066
- Email: angela.summers@mft.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Microbiome following transplantation
Time Frame: 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
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Titus Augustine, FRCP, Consultant Transplant Surgeon
- Principal Investigator: Oana Piscoran, MD, Clinical Research Fellow
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B00150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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