Study on Colonic Fermentation in Chronic Kidney Disease Patients

NCT01874210 | Completed

• 1 other identifier: S51367
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• difference in fecal metabolite profile depending on dialysis modality

  baseline

Study Arms (2)

Hemodialysis

Hemodialysis patients

Control

1. Household contacts on the same diet 2. Healthy unrelated controls

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal sample, serum

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ruben Poesen, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Björn Meijers, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Kristin Verbeke, Pharm PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Pieter Evenepoel, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: February 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

BE (1)