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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Diarrhea

In brief

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.

Key facts

Study ID

NCT00911612

Run by

Mayo Clinic

People needed

24

Starts

2009-01-01

Expected to finish

2009-05-01

Last updated by the study team

2012-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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