CompletedPhase 2

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

United States24 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Colonic Transit, Geometric Center at 24 Hours

Timeframe: After 12-14 days treatment

Ascending Colon Emptying T1/2

Timeframe: After 12-14 days' treatment

Trial details

NCT IDNCT00911612

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-05

Results submitted2012-02-10

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials