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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hemodialysis; Hemodialysis patients
Control; Household contacts on the same diet; Healthy unrelated controls

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Pieter Evenepoel, MD, PhD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Kristin Verbeke, Pharm PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: S51367