Status:
WITHDRAWN
The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Constipation
Eligibility:
All Genders
18-85 years
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01869751
Start Date
May 1 2013
End Date
December 1 2018
Last Update
April 24 2020
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000