Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
welchol
A Phase IIB Study to Evaluate the Effects of Welchol (Colesevelam Hydrochloride) on Colonic Transit, Intestinal Permeability and Bowel Function in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)
2 other identifiers
interventional
24
1 country
1
Brief Summary
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome. This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 2, 2009
CompletedResults Posted
Study results publicly available
March 15, 2012
CompletedApril 4, 2012
March 1, 2012
4 months
May 29, 2009
February 10, 2012
March 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Colonic Transit, Geometric Center at 24 Hours
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.
After 12-14 days treatment
Ascending Colon Emptying T1/2
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.
After 12-14 days' treatment
Secondary Outcomes (3)
Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours
after 12-14 days' treatment
Colonic Transit, Geometric Center at 48 Hours
After 12-14 days' treatment
Stool Consistency
After 12-14 days' treatment
Study Arms (2)
Colesevelam
EXPERIMENTALParticipants received colesevelam 1.875 g twice daily
Placebo
PLACEBO COMPARATORParticipants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
Interventions
Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days
Eligibility Criteria
You may qualify if:
- Patients with D-IBS
- Aged 18-65 years
- No abdominal surgery (except appendectomy or cholecystectomy as long as patients IBS-diarrhea symptoms preceded the cholecystectomy
You may not qualify if:
- Participants with known chronic liver disease or Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \> 2.0 X upper limit of normal
- Hypertriglyceridemia and pancreatitis by history
- Diabetes or hypoglycemia
- Significant coagulation disorder
- History of bowel obstruction
- Serum triglycerides \>500 mg/dL
- History of vitamin A, D, E, or K deficiencies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (2)
Fernandez-Banares F, Esteve M, Salas A, Alsina M, Farre C, Gonzalez C, Buxeda M, Forne M, Rosinach M, Espinos JC, Maria Viver J. Systematic evaluation of the causes of chronic watery diarrhea with functional characteristics. Am J Gastroenterol. 2007 Nov;102(11):2520-8. doi: 10.1111/j.1572-0241.2007.01438.x. Epub 2006 Aug 4.
PMID: 17680846BACKGROUNDOdunsi-Shiyanbade ST, Camilleri M, McKinzie S, Burton D, Carlson P, Busciglio IA, Lamsam J, Singh R, Zinsmeister AR. Effects of chenodeoxycholate and a bile acid sequestrant, colesevelam, on intestinal transit and bowel function. Clin Gastroenterol Hepatol. 2010 Feb;8(2):159-65. doi: 10.1016/j.cgh.2009.10.020. Epub 2009 Oct 30.
PMID: 19879973RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Camilleri
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L. Camilleri, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 2, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 4, 2012
Results First Posted
March 15, 2012
Record last verified: 2012-03