peer reviewed ; OBJECTIVES: Diarrhea is one of the main symptoms of Crohn's disease (CD). It is usually significantly improved with specific CD treatments, loperamide or cholestyramine. However, in some cases, diarrhea becomes refractory. The aim of this study was to assess the safety and efficacy of octreotide in this situation. MATERIALS AND METHODS: Fifteen patients with CD refractory diarrhea defined by at least an average of five smooth or liquid stools per day despite an optimized CD treatment were included from three Belgian centers. Two patients were lost to follow-up. A subcutaneous injection of 100 mug octreotide was performed three times a day during three days. When the drug had been well tolerated, an intramuscular injection of 30 mg octreotide (Sandostatin(R) LAR 30) was realized. Evaluation was done at day 31. The primary endpoint was to assess the effect on the mean number of smooth or liquid stools per day. RESULTS: A significant reduction (p = 0.0001) of the average number of smooth or liquid stools over the last seven days was observed between baseline and day 31. The maximum number of smooth or liquid stools also significantly decreased (p = 0.0009). Four patients (26.7%) presented mild nonspecific adverse events but no serious one. We also observed a significant decrease (p = 0.0006) of the Harvey-Bradshaw Index (HBI) and a significant improvement (p = 0.0012) of the inflammatory bowel disease questionnaire (IBDQ). CONCLUSIONS: In this uncontrolled open-label study, octreotide appeared safe and effective in CD refractory diarrhea, in addition to CD treatments. It significantly improved the number of liquid or smooth stools, the HBI and the IBDQ.