Trial · NCT00911612

Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?

NCT00911612, Phase 2, Completed, Mayo Clinic; results first posted 2012-03-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)? Trials, record NCT00911612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00911612

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
NCT number: NCT00911612
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Irritable Bowel Syndrome, Diarrhea
Interventions: Colesevelam, Placebo
First posted: 2009-06-02
Last updated: 2012-04-04
Results first posted: 2012-03-15

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Colonic Transit, Geometric Center at 24 Hours	After 12-14 days treatment	The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Primary	Ascending Colon Emptying T1/2	After 12-14 days' treatment	The half time for the ascending colon emptying (T1/2) was measured by the scintigraphic method. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule that is swallowed by the subject. Anterior and posterior gamma images are taken hourly. From the hourly scans, a time-activity curve is plotted using linear interpolation between time points when content was measured. The time taken to empty 50% of the isotope from the ascending colon is read from this time-activity curve.
Secondary	Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours	after 12-14 days' treatment	Colonic permeability is measured through differential excretion of urine saccharides. The subject ingests a methacrylate-coated capsule that contains saccharides (mannitol 1g and lactulose 5 g powder). The capsule provides a means to protect the sugars from absorption, until the sugars are delivered to the colon by means of a standard delayed release capsule. The value reported is the mean for each arm of the total amount of mannitol excreted over the 8-24 hour time period.
Secondary	Colonic Transit, Geometric Center at 48 Hours	After 12-14 days' treatment	The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Secondary	Stool Consistency	After 12-14 days' treatment	The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Colonic Transit, Geometric Center at 24 Hours	After 12-14 days treatment	units on a scale	MEAN
PRIMARY	Ascending Colon Emptying T1/2	After 12-14 days' treatment	hours	MEAN
SECONDARY	Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours	after 12-14 days' treatment	mg	MEAN
SECONDARY	Colonic Transit, Geometric Center at 48 Hours	After 12-14 days' treatment	units on a scale	MEAN
SECONDARY	Stool Consistency	After 12-14 days' treatment	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Colonic Transit, Geometric Center at 24 Hours	Colesevelam	2.68	Standard Error 0.32	units on a scale
Colonic Transit, Geometric Center at 24 Hours	Placebo	3.30	Standard Error 0.33	units on a scale
Ascending Colon Emptying T1/2	Colesevelam	18.85	Standard Error 2.88	hours
Ascending Colon Emptying T1/2	Placebo	14.9	Standard Error 3.58	hours
Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours	Colesevelam	64.3	Standard Error 13.3	mg
Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours	Placebo	45.8	Standard Error 8.8	mg
Colonic Transit, Geometric Center at 48 Hours	Colesevelam	4.65	Standard Error 0.13	units on a scale
Colonic Transit, Geometric Center at 48 Hours	Placebo	4.47	Standard Error 0.20	units on a scale
Stool Consistency	Colesevelam	3.78	Standard Error 0.27	units on a scale
Stool Consistency	Placebo	4.57	Standard Error 0.35	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Colesevelam	12
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	Colesevelam	12
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Colesevelam	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Uterine cramps	Reproductive system and breast disorders	Colesevelam	1	12	1
other	Uterine cramps	Reproductive system and breast disorders	Placebo	2	12	2
other	Headache	Nervous system disorders	Colesevelam	5	12	5
other	Headache	Nervous system disorders	Placebo	4	12	4
other	Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Colesevelam	1	12	1
other	Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Placebo	4	12	4
other	Lower abdominal cramps	Gastrointestinal disorders	Colesevelam	2	12	2
other	Lower abdominal cramps	Gastrointestinal disorders	Placebo	0	12	0
other	Flatulence	Gastrointestinal disorders	Colesevelam	3	12	3
other	Flatulence	Gastrointestinal disorders	Placebo	1	12	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Colesevelam
Total, all-cause mortality	Placebo
Total, other adverse events	Colesevelam	12	12
Total, other adverse events	Placebo	9	12
Total, serious adverse events	Colesevelam	0	12
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17680846	BACKGROUND	PubMed
19879973	RESULT	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK054681	Alpha-2 Adrenergic Control of Colonic Function in IBS	CAMILLERI, MICHAEL L	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	1999 to 2007

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Colesevelam vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00911612

GET https://conductscience.org/api/trials/v1/NCT00911612/registered

API reference For AI assistants