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NCT04714853 Clinical Trial

Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04714853
Other study ID # 15/0308
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2015
Est. completion date December 2024

Study information
Verified date January 2021
Source University College, London
Contact vashist deelchand
Phone 02077940500
Email vashist.deelchand@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Free Hospital London

Sponsors (2)
Lead Sponsor Collaborator
University College, London University of Brighton

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 measure indoxyl sulphate (IS) and p-Cresyl sulfate (PCS) umol/L observational 8 years
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