Table 4.
Adequate Relief of Constipation—measured at Day 0 (baseline) and Day 28 (end of study)—in the ITT and BMF≤3/week populations.
| ITT |
BMF≤3/week |
|||||||
| |
Total |
High dose |
Low dose |
Placebo |
Total |
High dose |
Low dose |
Placebo |
| Day 0 | ||||||||
| No | 112 (49.1%) | 34 (44.7%) | 34 (44.7%) | 44 (57.9%) | 45 (69.2%) | 12 (63.2%) | 15 (65.2%) | 18 (78.3%) |
| Yes | 116 (50.9%) | 42 (55.3%) | 42 (55.3%) | 32 (42.1%) | 20 (30.8%) | 7 (36.8%) | 8 (34.8%) | 5 (21.7%) |
| Day 28 | ||||||||
| Missing | 4 (1.8%) | 2 (2.6%) | 2 (2.6%) | — | — | — | — | — |
| No | 78 (34.2%) | 29 (38.2%) | 27 (35.5%) | 22 (28.9%) | 26 (40.0%) | 7 (36.8%) | 10 (43.5%) | 9 (39.1%) |
| Yes | 146 (64.0%) | 45 (59.2%) | 47 (61.8%) | 54 (71.1%) | 39 (60.0%) | 12 (63.2%) | 13 (56.5%) | 14 (60.9%) |
| Δ | ||||||||
| Missing | 4 (1.8%) | 2 (2.6%) | 2 (2.6%) | — | — | — | — | — |
| Improvement | 55 (24.1%) | 14 (18.4%) | 17 (22.4%) | 24 (31.6%) | 22 (33.8%) | 5 (26.3%) | 8 (34.8%) | 9 (39.1%) |
| No change | 146 (64.0%) | 50 (65.8%) | 46 (60.5%) | 50 (65.8%) | 40 (61.5%) | 14 (73.7%) | 12 (52.2%) | 14 (60.9%) |
| Worsening | 23 (10.1%) | 10 (13.2%) | 11 (14.5%) | 2 (2.6%) | 3 (4.6%) | — | 3 (13.0%) | — |
BMF≤3/week, participants from the ITT population who had fewer than or equal to 3 bowel movements per week during the entire 14-day run-in period; high-dose group, 1 × 1010 CFU of HN019/day; ITT, intention-to-treat population—all participants randomized at the second visit who consumed at least 1 dose of the study product; low-dose group 1 × 109 CFU of HN019/day. ‘-‘, no value. Values are number of participants (%).