Status:
COMPLETED
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Irritable Bowel Syndrome
Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ir...
Detailed Description
Background: Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to side eff...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00911612
Start Date
January 1 2009
End Date
May 1 2009
Last Update
April 4 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905