Table 3.
Summary of efficacy outcomes at the end of study (day 90): (full analysis set, last observation carried forward, ANCOVA model, 95% CI)
| Efficacy parameters | Bacillus coagulans MTCC 5856 (n = 20) | Placebo (n = 20) | Δ p-value |
|---|---|---|---|
| Primary efficacy outcomes | |||
| HAM-D | |||
| Base line (Day 0) | 13.6 ± 4.41 | 14.5 ± 3.41 | 0.474 |
| End of the study (Day 90) | 5.9 ± 4.88 | 12.5 ± 8.70 | 0.005* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.333 | 0.029* |
| MADRS | |||
| Base line (Day 0) | 16.3 ± 5.40 | 17.1 ± 4.63 | 0.618 |
| End of the study (Day 90) | 6.0 ± 5.79 | 12.6 ± 8.00 | 0.007* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.056 | 0.031* |
| CES-D | |||
| Base line (Day 0) | 19.1 ± 5.25 | 20.7 ± 4.86 | 0.323 |
| End of the study (Day 90) | 8.0 ± 6.17 | 16.7 ± 13.03 | 0.009* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.224 | 0.051* |
| IBS-QOL | |||
| Base line (Day 0) | 106.4 ± 23.44 | 102.6 ± 21.11 | 0.595 |
| End of the study (Day 90) | 56.1 ± 31.26 | 84.1 ± 34.67 | 0.010* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.075 | 0.027* |
| Secondary efficacy outcomes | |||
| CGI-I | |||
| Base line (Day 0) | 3.7 ± 0.87 | 3.8 ± 1.01 | 0.835 |
| End of the study (Day 90) | 2.3 ± 0.92 | 3.2 ± 1.09 | 0.011* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.096 | 0.141 |
| CGI-S | |||
| Base line (Day 0) | 3.4 ± 0.96 | 3.7 ± 0.92 | 0.277 |
| End of the study (Day 90) | 2.3 ± 0.92 | 3.1 ± 1.05 | 0.022* |
| Change from baseline to day 90 | p = 0.009* | p = 0.058 | 0.396 |
| Dementia – TFS | |||
| Base line (Day 0) | 62.3 ± 17.08 | 61.3 ± 19.11 | 0.862 |
| End of the study (Day 90) | 45.9 ± 26.42 | 64.0 ± 28.26 | 0.043* |
| Change from baseline to day 90 | p = 0.0046* | p = 0.592 | 0.011* |
| Dementia – TRS | |||
| Base line (Day 0) | 63.8 ± 17.57 | 61.0 ± 19.83 | 0.645 |
| End of the study (Day 90) | 51.6 ± 28.19 | 61.8 ± 29.94 | 0.118 |
| Change from baseline to day 90 | p = 0.047* | p = 0.880 | 0.103 |
| GI-DQ | |||
| Base line (Day 0) | 30.1 ± 15.07 | 32.5 ± 13.88 | 0.596 |
| End of the study (Day 90) | 11.4 ± 18.23 | 22.9 ± 14.55 | 0.035* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.058 | 0.132 |
| mESS | |||
| Base line (Day 0) | 10.3 ± 2.43 | 10.9 ± 2.99 | 0.490 |
| End of the study (Day 90) | 4.2 ± 3.92 | 8.9 ± 6.24 | 0.007* |
| Change from baseline to day 90 | p ≤ 0.001* | p = 0.171 | 0.018* |
Δ Between-group comparisons were made using the ANCOVA. Within-group comparisons were made using the paired Student’s t-test. *Probability (p) values ≤0.05 are statistically significant.
ANCOVA, analysis of covariance; CES-D, Center for Epidemiological Studies Depression Scale; CGI-I, Clinical Global Impression-Improvement rating Scale; CGI-S, Clinical Global Impression Severity Rating Scale; CI, confidence interval; GI-DQ, Gastrointestinal Discomfort Questionnaire; HAM-D, Hamilton Rating Scale for Depression; IBS-QOL, Irritable Bowel Syndrome Quality of Life Questionnaire; MADRS, Montgomery–Asberg Depression Rating Scale; mESS, Modified Epworth Sleepiness Scale; Dementia – TFS, Dementia – Total frequency scoring; Dementia – TRS, Dementia – Total reaction scoring.
p-value significant (<0.05).
Values are expressed as mean ± SD.