Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease

NCT ID: NCT01752738

Last Updated: 2024-07-03

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

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2025-12-31

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. 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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bjorn Meijers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Sander Dejongh

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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University Hospitals Leuven

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sander Derjongh

Role: CONTACT

+ 32 16 342352

Bjorn Meijers, MD, PhD

Role: CONTACT

+32 16 344 580

Other Identifiers

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S54909

Identifier Type: -

Identifier Source: org_study_id

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