Table 2 Frequency of stool and diapers with stool by visit (ITT population)
|  | B. clausii (n = 229) | Placebo (n = 228) |
|---|---|---|
No. of unusual stools within 48 h of visit 1 | ||
 Number | 229 | 228 |
 Mean [SD] | 10.2 [5.3] | 10.1 [5.3] |
 0 times | 0 | 0 |
 1 time | 0 | 0 |
 2 times | 0 | 0 |
 3 times | 0 | 2 (0.9) |
  > 3 times | 229 (100.0) | 226 (99.1) |
No. of unusual stools within 24 h of visit 1 | ||
 Number | 229 | 228 |
 Mean [SD] | 6.3 [4.0] | 6.6 [4.3] |
 0 times | 0 | 0 |
 1 time | 0 | 0 |
 2 times | 0 | 0 |
 3 times | 30 (13.1) | 26 (11.4) |
  > 3 times | 199 (86.9) | 202 (88.6) |
Day 1 | ||
 Total no. of stools and diapers with stool | ||
  Number | 229 | 228 |
  Mean [SD] | 4.6 [2.3] | 4.9 [2.4] |
  0 times | 1 (0.4) | 2 (0.9) |
  1 time | 2 (0.9) | 2 (0.9) |
  2 times | 37 (16.2) | 28 (12.3) |
  3 times | 37 (16.2) | 35 (15.4) |
  > 3 times | 152 (66.4) | 161 (70.6) |
Day 2 | ||
 Total no. of stools and diapers with stool | ||
  Number | 228 | 227 |
  Mean [SD] | 3.8 [2.5] | 3.8 [2.3] |
  0 times | 2 (0.9) | 1 (0.4) |
  1 time | 19 (8.3) | 24 (10.6) |
  2 times | 49 (21.5) | 46 (20.3) |
  3 times | 68 (29.8) | 57 (25.1) |
  > 3 times | 90 (39.5) | 99 (43.6) |
Day 3 | ||
 Total no. of stools and diapers with stool | ||
  Number | 225 | 226 |
  Mean [SD] | 2.4 [2.0] | 2.5 [1.8] |
  0 times | 3 (1.3) | 4 (1.8) |
  1 time | 79 (35.1) | 75 (33.2) |
  2 times | 70 (31.1) | 62 (27.4) |
  3 times | 31 (13.8) | 44 (19.5) |
  > 3 times | 42 (18.7) | 41 (18.1) |
Day 4 | ||
 Total no. of stools and diapers with stool | ||
  Number | 211 | 214 |
  Mean [SD] | 2.0 [2.1] | 2.0 [1.8] |
  0 times | 2 (0.9) | 2 (0.9) |
  1 time | 112 (53.1) | 111 (51.9) |
  2 times | 55 (26.1) | 57 (26.6) |
  3 times | 21 (10.0) | 24 (11.2) |
  > 3 times | 21 (10.0) | 20 (9.3) |
Day 5 | ||
 Total no. of stools and diapers with stool | ||
  Number | 200 | 201 |
  Mean [SD] | 1.7 [1.7] | 1.6 [1.2] |
  0 times | 2 (1.0) | 2 (1.0) |
  1 time | 135 (67.5) | 121 (60.2) |
  2 times | 41 (20.5) | 51 (25.4) |
  3 times | 10 (5.0) | 15 (7.5) |
  > 3 times | 12 (6.0) | 12 (6.0) |