[Effect of BMY-28100 on bacterial flora in adult human feces]

We investigated effects of BMY-28100 on fecal bacteria. BMY-28100 was administered orally to 8 healthy male volunteers between 20 and 24 years of age weighing between 58.0 and 79.5 kg. All subjects were given one 250 mg capsule 3 times a day at 30 minutes after meal for 7 days. Fecal bacterial counts were examined 5 days before the start of administration, the day of the start of administration, 3, 5 and 7 days after the start of administration, and 3, 5, 10, 20 and 30 days after the end of administration. Concentrations of BMY-28100 and Clostridium difficile D-1 toxin in feces were also examined together with examinations for adverse reactions and abnormal laboratory test values. 1. Total aerobic bacterial counts increased transiently upon the antibiotic dosage. Escherichia coli and yeast like organism increased transiently during the period of administration, while the total counts of anaerobic bacteria remained constant. Veillonellaceae, Peptococcaceae and Eubacterium decreased transiently during the period of administration. Although C. difficile and its D-1 toxin were detected in 1 and 5 cases, respectively, these feces appeared normal. 2. Active metabolites of BMY-28100 were not detected in the feces. 3. No adverse effects or no abnormal laboratory test values were observed.