Different Dialysis Modalities and Diet on Gastrointestina... | NCT04714853

Studies
Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

NCT04714853

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Jan 19, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Kidney Failure

Interventions

Not provided

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

Jan 2021

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

Oct 2015

Primary Completion Date

Aug 2023Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Jan 15, 2021

First Posted Date

Jan 19, 2021Actual

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

Jan 15, 2021

Last Update Posted Date

Jan 19, 2021Actual

Name	Class
University of Brighton	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

. This is a prospective observational pilot study to analyse gastrointestinal tract bacterial populations in peritoneal dialysis and haemodialysis patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular haemodialysis and peritoneal dialysis treatments in a Royal Free Hospital kidney care centre.

Detailed Description

Patients, attending for outpatient haemodialysis and peritoneal dialysis to be tested for gastrointestinal tract bacterial population by taking a single mouth swab, and a stool sample. Additional blood sampling, when patients are having blood tests for routine clinical assessment.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
generation of bacterial phylogenetic trees by identifying different bacteria from stool samples and oral swabs by analysis of bacterial ribosomal 16S	observational	5 years

Secondary Outcomes

Measure	Description	Time Frame
measure indoxyl sulphate (IS) and p-Cresyl sulfate (PCS) umol/L	observational	8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients age 18 years and older up to 80 years
Under the care of the Royal Free Hospital with chronic kidney disease and established on regular haemodialysis or peritoneal dialysis.
Able to provide written informed consent obtained

Exclusion Criteria:

Patients unable to provide written informed consent
Patients not fulfilling inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

100 dialysis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
vashist deelchand	Contact	02077940500		vashist.deelchand@nhs.net
ruth yang	Contact	02077940500		ruth.yang@nhs.net

Overall Officials

Name	Affiliation	Role
andrew davenport	UCL Centre for Nephrology, Royal Free Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Free Hospital	Recruiting	London		NW32QG	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

data to be deposited with UCL

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided