Table 2 Primary and secondary outcomes
Overall (n = 33) | Bif195 (n = 16) | Placebo (n = 17) | p-value | |
|---|---|---|---|---|
Primary outcome | ||||
Reduction in BWT | ||||
1. A reduction of BWT by ≥ 25% OR 2 mm | ||||
Yes (%) | 4 (25) | 4 (24) | ||
No (%) | 12 (75) | 13 (77) | ||
2. A 2-point CDI reduction | ||||
Yes (%) | 1 (6) | 2 (12) | ||
No (%) | 15 (94) | 15 (88) | ||
Reduction in BWT (1 and 2) | ||||
Yes (%) | 5 (31) | 5 (29) | 0.73a | |
No (%) | 11 (69) | 12 (71) | ||
Secondary outcomes | ||||
F-calprotectin (μg/g), median (IQR) | ||||
Baseline | 482 (639) | 484 (566) | 482 (947) | 0.35b |
After 8 weeks | 446 (977) | 425 (632) | 446 (1183) | |
Change from baseline | 34 (391) | 46 (451) | 22 (299) | |
IBUS-SAS score, mean (SD) | ||||
Baseline | 49 (22) | 53 (23) | 46 (22) | |
After 8 weeks | 41 (23) | 42 (26) | 40 (21) | |
Change from baseline | − 8 (21) | − 11 (20) | − 6 (22) | 0.75b |
Transmural remission | ||||
BWT ≤ 3 mm | ||||
Yes (%) | 4 (25) | 3 (18) | 0.61c | |
No (%) | 12 (75) | 14 (82) | ||
HBI score, mean (SD) | ||||
Baseline | 1.7 (2.5) | 0.9 (1.0) | 2.5 (3.2) | |
After 8 weeks | 1.6 (2.1) | 1.1 (1.3) | 2.1 (2.5) | |
Change from baseline | − 0.2 (2.0) | 0.2 (1.5) | − 0.5 (2.4) | 0.78b |
IBDQ score, mean (SD) | ||||
Baseline | 192 (19) | 193 (18) | 192 (21) | |
After 8 weeks | 194 (18) | 195 (17) | 194 (19) | |
Change from baseline | 2 (14) | 2 (12) | 2 (16) | 0.88b |