This study was performed to estimate the maximum no-effect dose level and the 50% effective dose (ED50) lactitol in causing diarrhea. Fifty-six healthy male and female subjects at the ages of twenties to fifties were enrolled in study. The maximum no-effect dose level of lactitol was 0.075g/kg in males and 0.15g/kg in females. The ED50 was 0.36g/kg in males and 0.43g/kg in females. (Fig. 2) Major abdominal symptoms caused by ingestion of lactitol were borborygmus, abdominal distension, and flatus, and lower abdominal pain with large doses. (Fig. 6).
