Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: a randomized, double-blind, placebo-controlled study

J Crohns Colitis. 2014 Nov;8(11):1471-9. doi: 10.1016/j.crohns.2014.05.009. Epub 2014 Jun 19.


Background and aims: Bile acid malabsorption (BAM)-associated diarrhea is an important clinical issue in patients with Crohn's disease (CD). We analyzed the efficacy and safety of the bile acid sequestrant colesevelam for treatment of BAM-associated diarrhea in CD patients in a randomized, double-blind, placebo-controlled study.

Methods: The primary endpoint was the proportion of patients with >30% reduction of liquid stools/day from baseline to termination visit at week 4. Secondary endpoints were reduction of the number of liquid stools/day, improvement of stool consistency and quality of life.

Results: 26 patients were analyzed in the intention-to-treat (ITT) analysis. The primary endpoint was reached by 10 patients (69.7%) in the colesevelam group compared to 3 patients (27.3%) in the placebo group (risk difference RD=.394, 95%CI:[-0.012; 0.706]; P=.0566). In the per-protocol analysis (n=22), the risk difference was statistically significant (RD=.470, 95%CI:[0.018; 0.788], P(H0: RD=0)=0.0364; 95% CI:[1.3;54.7]). Regarding secondary endpoints, in the ITT population colesevelam-treated patients had a significant reduction of liquid stools/day at week 4 (median 5.0 to 2.0; P=0.01), while patients treated with placebo had no significant reduction (median 4.0 to 3.0; P=0.42). Significantly more patients in the colesevelam group had improvement of stool consistency of at least one level in the Bristol stool chart, as compared to the placebo group (P=0.003).

Conclusions: We found significant differences in favor for colesevelam treatment compared to placebo treatment for CD patients with BAM regarding the reduction of the number of liquid stools/day and stool consistency. number: NCT01203254.

Keywords: Bile acid malabsorption; Colesevelam; Crohn's disease; Diarrhea.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Allylamine / adverse effects
  • Allylamine / analogs & derivatives*
  • Allylamine / therapeutic use
  • Anticholesteremic Agents / adverse effects
  • Anticholesteremic Agents / therapeutic use*
  • Bile Acids and Salts / metabolism*
  • Cholestenones / blood
  • Colesevelam Hydrochloride
  • Crohn Disease / complications*
  • Crohn Disease / surgery
  • Diarrhea / blood
  • Diarrhea / drug therapy*
  • Diarrhea / etiology
  • Double-Blind Method
  • Feces
  • Female
  • Humans
  • Intention to Treat Analysis
  • Malabsorption Syndromes / blood
  • Malabsorption Syndromes / drug therapy*
  • Malabsorption Syndromes / etiology
  • Male
  • Middle Aged
  • Quality of Life
  • Treatment Outcome


  • Anticholesteremic Agents
  • Bile Acids and Salts
  • Cholestenones
  • Allylamine
  • Colesevelam Hydrochloride

Associated data