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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01869751
Collaborator
(none)
0
Enrollment
1
Location
67
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Prucalopride

Slow-transit constipation with treatment with prucalopride

Drug: Prucalopride
Treatment with prucalopride for slow-transit constipation

Outcome Measures

Primary Outcome Measures

  1. change in serum concentration of bacterial metabolites [4 weeks]

    change in serum concentration of bacterial metabolites before and after (4 weeks) treatment of prucalopride

Secondary Outcome Measures

  1. change in 24h urinary excretion rate of bacterial metabolites [4 weeks]

    change in 24h urinary excretion rate of bacterial metabolites before and after (4 weeks) treatment of prucalopride

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥ 18 and ≤ 85 years

  • Chronic slow-transit constipation as defined be 4 criteria:

  1. having two or fewer spontaneous complete bowel movements week for a minimum of 6 months

  2. 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.

  3. slow transit time as determined by Rx colon transit study ("pellet")

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Ruben Poesen, MD, Universitaire Ziekenhuizen Leuven
  • Principal Investigator: Björn Meijers, MD, PhD, Universitaire Ziekenhuizen Leuven
  • Principal Investigator: Jan Tack, MD, PhD, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01869751
Other Study ID Numbers:
  • S55296
First Posted:
Jun 5, 2013
Last Update Posted:
Apr 24, 2020
Last Verified:
Apr 1, 2020
Additional relevant MeSH terms:
Constipation
Prucalopride

Study Results

No Results Posted as of Apr 24, 2020