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The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?

NCT01869751 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-04-24

No results posted yet for this study

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. Colonic transit time is an important determinant of intestinal generation and uptake of bacterial metabolites. However, it is unknown if accelerating the colonic transit time reduces the intestinal generation and uptake of indoxyl sulfate and p-cresyl sulfate. Prucalopride is a selective, high-affinity 5-HT4 receptor agonist with a stimulating effect on colonic motility and transit. It is currently used in treating chronic slow-transit constipation. An observational study will be initiated in non-chronic kidney disease patients with chronic slow-transit constipation necessitating treatment with prucalopride to observe its effect on serum concentrations and intestinal generation of indoxyl sulfate and p-cresyl sulfate.

Conditions

Interventions

DRUG

Prucalopride

Treatment with prucalopride for slow-transit constipation

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Ruben Poesen, MD · Universitaire Ziekenhuizen KU Leuven

  • Björn Meijers, MD, PhD · Universitaire Ziekenhuizen KU Leuven

  • Jan Tack, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869751 on ClinicalTrials.gov