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INTRODUCTION: Crofelemer, the active compound purified from latex of Croton lechleri, has been shown to improve HIV and traveler's diarrhea and improve pain in women with irritable bowel syndrome–diarrhea (IBS-D). This trial evaluated the effect of crofelemer on abdominal pain in women with IBS-D. METHODS: Women with IBS-D were randomized to crofelemer (125 mg) or placebo twice daily for 12 weeks. The primary efficacy endpoint was overall change in percentage of abdominal pain/discomfort-free days. Post hoc analysis for Food and Drug Administration (FDA) monthly responders was performed for stool consistency, abdominal pain, and combined stool consistency and abdominal pain. RESULTS: A total of 240 women were enrolled. There was no significant difference in overall percentage of pain/discomfort-free day between the groups. In post hoc analysis, FDA abdominal pain monthly responders were significantly more likely during months 1 through 2 (58.3% vs 45.0%, P = 0.030) as well as during the entire 3 months (54.2% vs 42.5%, P = 0.037) in the crofelemer group when compared with placebo. However, there was no significant difference in the percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders between the groups. Crofelemer had a safety profile similar to placebo. DISCUSSION: Crofelemer did not significantly improve abdominal pain over placebo by the primary endpoint. However, it did based on the FDA abdominal pain monthly responder endpoint. This suggests that crofelemer may have a role in the treatment of abdominal pain associated with IBS-D. Further studies are warranted to evaluate the potential of crofelemer as a visceral analgesic.

Background Fecal urgency is a symptom generally associated with diarrhea but is also reported by patients with constipation. Our aim was to (a) assess the prevalence and burden of fecal urgency in constipated patients (b) evaluate gastrointestinal and psychiatric predictors of moderate to severe fecal urgency in these patients. Methods Patients presenting consecutively to a tertiary outpatient gastroenterology clinic with constipation were included. Patients were considered to have moderate to severe fecal urgency if ≥50% of bowel movements (BMs) in the past 3 months were associated with fecal urgency. Anxiety, depression, and sleep disturbance were diagnosed using a Patient‐Reported Outcomes Measurement Information System (PROMIS) t‐score of ≥60. Abdominal pain and constipation severity were also assessed using PROMIS questionnaires. Univariable and stepwise logistic regression were used to identify predictors of moderate to severe fecal urgency. Key results Of 139 constipated patients, 70.8% reported experiencing fecal urgency in the past 3 months and 25.8% reported being significantly bothered by it. Moderate to severe fecal urgency was reported by 27% of 139 patients. Frequency of loose stools (OR 1.5, 95% CI 1.1, 2.0) and presence of anxiety (OR 2.3, 95% CI 1.1, 5.0) were independent predictors of moderate to severe fecal urgency. Conclusions and inferences Fecal urgency is common in patients with constipation and is frequently bothersome to many patients. We identified clinical and psychiatric factors associated with moderate to severe fecal urgency in constipated patients with potential therapeutic implications if validated in future studies.

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