Study on Colonic Fermentation in Chronic Kidney Disease Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01874210

Enrollment

Registered

2013-06-10

Start date

2008-02-29

Completion date

2016-05-31

Last updated

2016-05-18

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

Conditions

Renal Insufficiency, Chronic

Brief summary

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Yes

Inclusion criteria

* Age ≥ 18 and ≤ 95 years * Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months * Written informed consent

Exclusion criteria

* History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy) * History of colonic surgery * Recipient of a renal or other solid organ transplant * Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks

Design outcomes

Primary

Measure	Time frame	Description
difference in fecal metabolite profile (Chronic kidney disease vs. control)	baseline	difference in fecal metabolite profile between chronic kidney disease patients and control group

Secondary

Measure	Time frame	Description
difference in fecal metabolite profile depending on dialysis modality	baseline	difference in fecal metabolite profile between hemodialysis patients and peritoneal patients

Countries

Belgium

Outcome results