Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?
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.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-05
- Completion
- 2009-05
Outcome
Mixed primary results
registry Colesevelam vs Placebo; p = 0.22; ANCOVA; note: Not adjusted since only one comparison was made. NCT00911612 ↗
registry MEAN Colesevelam: 2.68 (Standard Error 0.32) units on a scale NCT00911612 ↗
registry MEAN Placebo: 3.30 (Standard Error 0.33) units on a scale NCT00911612 ↗
registry Colesevelam vs Placebo; p = 0.02; ANCOVA NCT00911612 ↗
registry MEAN Colesevelam: 18.85 (Standard Error 2.88) hours NCT00911612 ↗
registry MEAN Placebo: 14.9 (Standard Error 3.58) hours NCT00911612 ↗
paper Emptying of the ascending colon took an average of 4 hours longer in patients given colesevelam compared with placebo PMID 19879973 ↗
Publications
- Background 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.
- Results Odunsi-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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colesevelam | Other / unclassified | 1.875 g | — |