Study on Colonic Fermentation in Chronic Kidney Disease Patients

Renal Insufficiency, Chronic Clinical Trial

Official title:

Study on Colonic Fermentation in Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874210
• Other study ID #: S51367
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: May 17, 2016
• Start date: February 2008
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in fecal metabolite profile (Chronic kidney disease vs. control)	difference in fecal metabolite profile between chronic kidney disease patients and control group	baseline	No
Secondary	difference in fecal metabolite profile depending on dialysis modality	difference in fecal metabolite profile between hemodialysis patients and peritoneal patients	baseline	No