Study on Colonic Fermentation in Chronic Kidney Disease Patients

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

difference in fecal metabolite profile (Chronic kidney disease vs. control)

Time frame: baseline

difference in fecal metabolite profile between chronic kidney disease patients and control group

Secondary outcomes

difference in fecal metabolite profile depending on dialysis modality

Time frame: baseline

difference in fecal metabolite profile between hemodialysis patients and peritoneal patients

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Jun 10, 2013
Registry last updated: May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed