Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

January 15, 2021 updated by: University College, London

Pilot Study to Determine the Effect of Different Dialysis Treatment Modalities and Diet on Gastrointestinal Bacteria and Azotaemic Toxins

. 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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, NW32QG
        • Recruiting
        • Royal Free Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 dialysis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 5 years
observational
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

University of Brighton

Investigators

  • Principal Investigator: andrew davenport, UCL Centre for Nephrology, Royal Free Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data to be deposited with UCL

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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