ConstipationNCT01869751
The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?
An observational study of Constipation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Constipation
- What is being tested?
- Prucalopride
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or newly diagnosed chronic slow-transit constipation necessitating treatment with prucalopride (Resolor®, Shire) according to current treatment guidelines
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Constipation
- Being tested
- Prucalopride
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Treatment with prucalopride for slow-transit constipation
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Slow-transit constipation with treatment with prucalopride Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum concentration of bacterial metabolites
change in serum concentration of bacterial metabolites before and after (4 weeks) treatment of prucalopride
Measured: 4 weeks
Secondary outcomes (1)
change in 24h urinary excretion rate of bacterial metabolites
change in 24h urinary excretion rate of bacterial metabolites before and after (4 weeks) treatment of prucalopride
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: failure to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben Poesen, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenBjörn Meijers, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenJan Tack, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869751
- Sponsor's protocol ID
- S55296
- Status last verified
- Apr 2020
- First submitted
- 31 May 2013
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?
- ClinicalTrials.gov ID
- NCT01869751
- Acronym / sponsor ID
- S55296
- Conditions
- Constipation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: failure to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | – | Drug: PrucaloprideSlow-transit constipation with treatment with prucalopride |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or newly diagnosed chronic slow-transit constipation necessitating treatment with prucalopride (Resolor®, Shire) according to current treatment guidelines
Key inclusion criteria (9 listed)
- Age ≥ 18 and ≤ 85 years
- Chronic slow-transit constipation as defined be 4 criteria:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideTreatment with prucalopride for slow-transit constipation | Drug | Prucalopride |
Primary outcome
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
1 secondary outcome
change in 24h urinary excretion rate of bacterial metabolites
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Poesen, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Björn Meijers, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Jan Tack, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum concentration of bacterial metabolites (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.