Changes in the Microbiome Associated With Transplantation | NCT04280627

Studies
Changes in the Microbiome Associated With Transplantation

NCT04280627

Sponsor

Manchester University NHS Foundation Trust

Status

Unknown status

Last Update Posted

Aug 16, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Microbiota

Interventions

Sample Collection

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2019Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 20, 2020

First Submission Date that Met QC Criteria

Feb 20, 2020

First Posted Date

Feb 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2023

Last Update Posted Date

Aug 16, 2023Actual

Name	Class
University of Manchester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sample Collection	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Kidney and Transplant Recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Titus Augustine, FRCP	Contact	0161 2763647	63647	titus.augustine@mft.nhs.uk
Angela Dr Summers, PhD	Contact	01617012066	12066	angela.summers@mft.nhs.uk

Overall Officials

Name	Affiliation	Role
Titus Augustine, FRCP	Consultant Transplant Surgeon	Principal Investigator
Oana Piscoran, MD	Clinical Research Fellow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manchester University NHS Foundationn Trust	Recruiting	Manchester	Greater Manchester	M13 9WL	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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