Study on Colonic Fermentation in Chronic Kidney Disease Patients

Completed

• Conditions: Renal Insufficiency, Chronic

• Registration Number: NCT01874210
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
difference in fecal metabolite profile depending on dialysis modality	baseline	difference in fecal metabolite profile between hemodialysis patients and peritoneal patients

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium