Study on Colonic Fermentation in Chronic Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis

Hemodialysis patients

No interventions assigned to this group

Control

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes