Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease
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Purpose
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. Mechanisms governing their intestinal uptake and metabolism, however, are currently unknown. The investigators aim to explore these transport characteristics in depth. Therefore, colonic biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to available data of healthy controls. Insights in the mechanisms controlling intestinal transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it might lead to novel therapeutic targets in the treatment of chronic kidney disease.
| Condition |
|---|
|
Chronic Kidney Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Influence of Chronic Kidney Disease on Intestinal Transport of Gut Microbial Metabolites |
- Percentage change in number of intestinal drug transporters and enzymes [ Time Frame: 4 years ] [ Designated as safety issue: No ]Influence of chronic kidney disease on intestinal drug transporters and enzymes responsible for uptake and metabolism of microbial metabolites
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be recruited from the nephrology outpatient clinic and dialysis center at University Hospital Leuven, Belgium.
Inclusion Criteria:
- Age ≥ 18 and ≤ 85 years
- Chronic kidney disease ≤ stage III (KDOQI), i.e., estimated glomerular filtration rate (MDRD) < 60 ml/min/m² or need of dialysis therapy 27
- Scheduled colonoscopy for diagnostic purposes
- Written informed consent
Exclusion Criteria:
- History of gastro-intestinal disease (e.g., inflammatory bowel disease)
- History of colon surgery
- Recipient of a renal or other solid organ transplant
- Exposure to antibiotics or drug therapy with a known influence on intestinal transporters (e.g., P-gp) or enzymes during 2 weeks before colonoscopy
Contacts and Locations| Contact: Ruben Poesen, MD | + 32 16 33 00 10 | ruben.poesen@uzleuven.be |
| Belgium | |
| University Hospitals Leuven | Recruiting |
| Leuven, Vlaams Brabant, Belgium, 3000 | |
| Principal Investigator: Ruben Poesen, MD | |
| Principal Investigator: Björn Meijers, MD, PhD | |
More Information
No publications provided
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01752738 History of Changes |
| Other Study ID Numbers: | S54909 |
| Study First Received: | December 11, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 18, 2013