- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869751
The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?
April 23, 2020 updated by: Universitaire Ziekenhuizen KU Leuven
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.
Study Overview
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospitals Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with known or newly diagnosed chronic slow-transit constipation necessitating treatment with prucalopride (Resolor®, Shire) according to current treatment guidelines
Description
Inclusion Criteria:
- Age ≥ 18 and ≤ 85 years
Chronic slow-transit constipation as defined be 4 criteria:
- having two or fewer spontaneous complete bowel movements week for a minimum of 6 months
- having one or more of the following symptoms for at least one-quarter of the time: lumpy/hard stools, a sensation of incomplete evacuation, or straining during defecation.
- slow transit time as determined by Rx colon transit study ("pellet")
- without evidence of secondary constipation or primary defecation disorder
- Need of therapy with prucalopride (i.e., inefficacy of dietary changes and laxatives)
- Follow-up visit possible after 4 weeks of treatment
- Written informed consent
Exclusion Criteria:
- History or new diagnosis of organic intestinal disease (e.g., inflammatory bowel disease, malignancy)
- Secondary constipation (drug-induced, endocrine, metabolic or neurological disorders, surgery, known or suspected organic disorders of the large intestine, or megacolon) or primary defecation disorder
- Use of laxatives two days before start of treatment and during treatment period. If there is no spontaneous bowel movement during 3 consecutive days, rescue treatment with bisacodyl and/or enema is allowed if necessary
- Presence of significant co-morbidity (uncontrolled heart, liver and lung disease)
- Pregnancy
- Chronic kidney disease, i.e., estimated glomerular filtration rate (MDRD) < 60 ml/min/m² or need of dialysis therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prucalopride
Slow-transit constipation with treatment with prucalopride
|
Treatment with prucalopride for slow-transit constipation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in serum concentration of bacterial metabolites
Time Frame: 4 weeks
|
change in serum concentration of bacterial metabolites before and after (4 weeks) treatment of prucalopride
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in 24h urinary excretion rate of bacterial metabolites
Time Frame: 4 weeks
|
change in 24h urinary excretion rate of bacterial metabolites before and after (4 weeks) treatment of prucalopride
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jan Tack, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
May 31, 2013
First Submitted That Met QC Criteria
May 31, 2013
First Posted (Estimate)
June 5, 2013
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S55296
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation
-
usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional Constipation (FC) | Chronic Idiopathic Constipation (CIC)United States, United Kingdom, Bulgaria, Netherlands
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
SK Life Science, Inc.CompletedChronic Constipation | Functional ConstipationUnited States
-
Cairo UniversityUnknownChronic Idiopathic Constipation | Functional ConstipationEgypt
-
ProgenaBiomeRecruitingConstipation | Constipation - Functional | Constipation Chronic Idiopathic | Constipation (Excl Faecal Impaction)United States
-
Pamukkale UniversityRecruiting
-
Shanghai University of Traditional Chinese MedicineLonghua Hospital; Shanghai Municipal Hospital of Traditional Chinese MedicineRecruiting
-
Universidade Nova de LisboaCINTESIS - Center for Health Technology and Services ResearchRecruiting
Clinical Trials on Prucalopride
-
MovetisCompleted
-
MovetisCompletedHepatic ImpairmentRussian Federation
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingPatient SatisfactionBangladesh
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
MovetisCompleted
-
ShireCompletedConstipationSpain, Romania, Italy, Poland, Czechia, Hungary, Slovakia, Sweden, Belgium
-
Janssen Korea, Ltd., KoreaCompletedConstipationKorea, Republic of
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingIrritable Bowel SyndromeBangladesh