Table 2.
Clinical improvement of symptoms at Week 8 (primary endpoint)
| B. clausii (n = 129) | Placebo (n = 130) | |
|---|---|---|
| Clinical improvement of symptoms at Week 8 with missing values replacementa, n (%) | ||
| Yes (responders) | 95 (73.6) | 102 (78.5) |
| No (non-responders) | 34 (26.4) | 28 (21.5) |
| 95% CI for proportion of responders | 67.3–80.0 | 72.5–84.4 |
| Difference in proportions between groups (B. clausii – placebo), % (95% CI) | − 4.8 (− 13.5 to 3.9) | |
| p-value | 0.8182 | |
| Clinical improvement of symptoms at Week 8 without missing values replacementa, n (%) | ||
| Yes (responders) | 95 (76.0) | 102 (79.1) |
| No (non-responders) | 30 (24.0) | 27 (20.9) |
| 95% CI for proportion of responders | 69.7–82.3 | 73.2–85.0 |
| Difference in proportions between groups (B. clausii—placebo), % (95% CI) | − 3.1 (− 11.7 to 5.5) | |
| p-value | 0.7212 | |
B. clausii Bacillus clausii; CI confidence interval
aClinical improvement of symptoms was defined as ‘Excellent’ or ‘Good’ to the questions “How well did the medication relieve your symptoms?” and ‘Better’ in “Overall how do you feel your problem is?” Missing values are assumed as non-responders
p-values are from the Chi-square test