NCT01869751|Withdrawn
Study Stopped
failure to recruit patients
Loading search results
Sponsor study identifier
observational
0
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 31, 2013
Actual (reported)June 5, 2013
Actual (reported)December 2018
Actual (reported)December 2018
Actual (reported)change in serum concentration of bacterial metabolites
change in serum concentration of bacterial metabolites before and after (4 weeks) treatment of prucalopride
4 weeks
change in 24h urinary excretion rate of bacterial metabolites
4 weeks
Slow-transit constipation with treatment with prucalopride
Treatment with prucalopride for slow-transit constipation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with known or newly diagnosed chronic slow-transit constipation necessitating treatment with prucalopride (Resolor®, Shire) according to current treatment guidelines
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
serum, urine
Ruben Poesen, MD
Universitaire Ziekenhuizen KU Leuven
Björn Meijers, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Jan Tack, MD, PhD
Universitaire Ziekenhuizen KU Leuven
0 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2013
First Posted
June 5, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
April 24, 2020
Record last verified: 2020-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: