Evaluation of crofelemer in the treatment of diarrhea-predominant irritable bowel syndrome patients

Digestion. 2008;78(4):180-6. doi: 10.1159/000185719. Epub 2008 Dec 18.


Background: Crofelemer improves bowel function in several conditions characterized by states of prominent secretory diarrhea.

Aim: This double-blind, randomized, placebo-controlled trial evaluated the effects of 3 dose levels of crofelemer in patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Methods: Male and female patients were randomly assigned to receive crofelemer 125, 250 or 500 mg or placebo twice daily for 12 weeks. The primary efficacy measure was a responder for improvement in stool consistency. In addition, abdominal pain- and discomfort-free days, pain and discomfort scores as well as other bowel function parameters (such as stool frequency and consistency, urgency, bloating) were evaluated.

Results: Two hundred and forty-two D-IBS patients were randomized. Crofelemer did not produce significant improvement in stool consistency (primary endpoint), stool frequency, urgency or adequate relief. However, female D-IBS patients showed improvement in the proportion of pain- and discomfort-free days during treatment with 500 mg crofelemer: month 1 (crofelemer vs. placebo: 17.7 vs. 10.2%, p = 0.098); month 2 (23.5 vs. 13.3%, p = 0.076); month 3 (26.1 vs. 10.6%, p = 0.0076). No benefit was seen in male D-IBS patients. Crofelemer was well tolerated.

Conclusions: Crofelelmer did not produce benefit on bowel function; an increase in the number of pain- and discomfort-free days in female D-IBS patients was seen. Further studies with crofelemer are warranted to evaluate it as a potential visceral analgesic.

Publication types

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

MeSH terms

  • Adult
  • Croton / chemistry*
  • Diarrhea / etiology*
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Irritable Bowel Syndrome / complications*
  • Irritable Bowel Syndrome / drug therapy*
  • Male
  • Middle Aged
  • Pain / etiology
  • Pain / physiopathology
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Proanthocyanidins / adverse effects
  • Proanthocyanidins / therapeutic use*
  • Sex Factors
  • Treatment Outcome


  • Plant Extracts
  • Proanthocyanidins
  • crofelemer