Table 7.
Gastrointestinal AEs in group 4
| Group and AE | No. (%) of subjects |
||||
|---|---|---|---|---|---|
| Placebo (n = 9) | VP20621 |
||||
| 104 spores (n = 9) | 106 spores (n = 9) | 108 spores (n = 9) | All doses (n = 27) | ||
| Subjects with ≥1 AE | 5 (56) | 5 (56) | 6 (67) | 1 (11) | 12 (44) |
| Subjects with ≥1 GI AE | 3 (33) | 4 (44) | 2 (22) | 0 | 6 (22) |
| Diarrhea | 0 | 2 (22) | 1 (11) | 0 | 3 (11) |
| Dyspepsia | 1 (11) | 1 (11) | 1 (11) | 0 | 2 (7) |
| Abdominal discomfort | 0 | 0 | 1 (11) | 0 | 1 (4) |
| Abdominal pain upper | 0 | 0 | 1 (11) | 0 | 1 (4) |
| Constipation | 0 | 1 (11) | 0 | 0 | 1 (4) |
| Flatulence | 2 (22) | 0 | 0 | 0 | 0 |
| Gingival pain | 1 (11) | 0 | 0 | 0 | 0 |