Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04714853

Enrollment

100

Registered

2021-01-19

Start date

2015-10-31

Completion date

2024-12-31

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

microbiome, haemodialysis, peritoneal dialysis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Contacts

Primary Contactvashist deelchand

vashist.deelchand@nhs.net02077940500

Backup Contactruth yang

ruth.yang@nhs.net02077940500

Outcome results