Table 5.
Subgroup analysis of cognitive tests by MMSE based on baseline MMSE scores
| Group | Baseline | Week 8 | Week 16 | Week 24 | ⊿ Week 24 | ||||||
| Mean (SD) | p | Mean (SD) | p | Mean (SD) | p | Mean (SD) | p | Mean (SD) | p | ||
| MMSE < 25 | |||||||||||
| MMSE total score | Probiotic | 23.29 (0.69) | 0.189 | 26.42 (2.26)*** | 0.899 | 27.29 (1.99)*** | 0.059 | 26.52 (2.52)*** | 0.909 | 3.26 (2.34) | 0.843 |
| Placebo | 23.52 (0.7) | 26.08 (3.1)*** | 26 (2.42)*** | 26.44 (2.58)*** | 2.96 (2.59) | ||||||
| Orientation in time | Probiotic | 4.5 (0.51) | 0.907 | 4.79 (0.42) | 0.757 | 4.79 (0.51) | 0.180 | 4.87 (0.63) | 0.006# | 0.35 (0.71) | 0.078 |
| Placebo | 4.37 (0.93) | 4.65 (0.75) | 4.44 (0.96) | 4.36 (1.04) | 0 (0.76) | ||||||
| Orientation in place | Probiotic | 4.63 (0.5) | 0.386 | 4.67 (0.76) | 0.427 | 4.83 (0.38) | 0.502 | 4.87 (0.34) | 0.108 | 0.26 (0.54) | 0.653 |
| Placebo | 4.41 (0.75) | 4.5 (0.86) | 4.72 (0.54) | 4.6 (0.65) | 0.2 (0.87) | ||||||
| Registration | Probiotic | 3 (0) | 0.366 | 2.96 (0.2) | 0.317 | 3 (0) | 1.000 | 3 (0) | 1.000 | 0 (0) | 1.000 |
| Placebo | 2.96 (0.19) | 3 (0) | 3 (0) | 3 (0) | 0 (0) | ||||||
| Serial-7 s | Probiotic | 1.25 (0.79) | 0.543 | 3.04 (1.83)*** | 0.968 | 3.29 (1.63)*** | 0.842 | 2.57 (1.88)** | 0.062 | 1.3 (2.1) | 0.313 |
| Placebo | 1.63 (1.45) | 3.12 (1.61)** | 3.16 (1.77)*** | 3.44 (1.45)*** | 1.88 (1.88) | ||||||
| Recall | Probiotic | 1.88 (0.85) | 0.617 | 2.5 (0.89)** | 0.857 | 2.67 (0.57)*** | 0.114 | 2.61 (0.66)*** | 0.850 | 0.74 (0.81) | 0.929 |
| Placebo | 1.78 (0.8) | 2.42 (0.99)** | 2.4 (0.65)** | 2.52 (0.82)*** | 0.72 (0.89) | ||||||
| Naming | Probiotic | 2 (0) | 1.000 | 2 (0) | 1.000 | 2 (0) | 1.000 | 2 (0) | 1.000 | 0 (0) | 1.000 |
| Placebo | 2 (0) | 2 (0) | 2 (0) | 2 (0) | 0 (0) | ||||||
| Repetition | Probiotic | 0.75 (0.44) | 0.723 | 0.83 (0.38) | 0.156 | 0.92 (0.28) | 0.026† | 0.83 (0.39) | 0.587 | 0.09 (0.6) | 0.970 |
| Placebo | 0.7 (0.47) | 0.65 (0.49) | 0.64 (0.49) | 0.76 (0.44) | 0.08 (0.57) | ||||||
| Three-stage command | Probiotic | 2.83 (0.38) | 0.129 | 2.88 (0.45) | 0.918 | 2.88 (0.34) | 0.620 | 2.91 (0.29) | 0.144 | 0.09 (0.42) | 0.599 |
| Placebo | 2.96 (0.19) | 2.92 (0.27) | 2.92 (0.28) | 3 (0) | 0.04 (0.2) | ||||||
| Reading | Probiotic | 0.96 (0.2) | 0.307 | 0.92 (0.28) | 0.524 | 1 (0) | 1.000 | 1 (0) | 0.359 | 0.04 (0.21) | 0.170 |
| Placebo | 1 (0) | 0.96 (0.2) | 1 (0) | 0.96 (0.2) | –0.04 (0.2) | ||||||
| Writing | Probiotic | 0.67 (0.48) | 0.235 | 0.88 (0.34) | 0.931 | 0.92 (0.28)* | 0.255 | 0.91 (0.29)* | 0.280 | 0.26 (0.45) | 0.045† |
| Placebo | 0.82 (0.4) | 0.89 (0.33) | 0.8 (0.41) | 0.8 (0.41) | 0 (0.41) | ||||||
| Construction | Probiotic | 0.83 (0.38) | 0.580 | 0.96 (0.2) | 0.977 | 1 (0) | 0.170 | 0.96 (0.21) | 0.317 | 0.13 (0.46) | 0.613 |
| Placebo | 0.89 (0.32) | 0.96 (0.2) | 0.92 (0.28) | 1 (0) | 0.08 (0.28) | ||||||
| MMSE≥25 | |||||||||||
| MMSE total score | Probiotic | 25.45 (0.51) | 0.620 | 27.26 (2.22)*** | 0.854 | 27.57 (2.11)*** | 0.317 | 27.54 (2.29)*** | 0.700 | 2.07 (2.16) | 0.701 |
| Placebo | 25.52 (0.51) | 27.15 (2.29)*** | 27.97 (2.3)*** | 27.88 (2.03)*** | 2.38 (2) | ||||||
| Orientation in time | Probiotic | 4.74 (0.58) | 0.866 | 4.55 (0.85) | 0.658 | 4.67 (0.61) | 0.229 | 4.79 (0.42) | 0.856 | 0.04 (0.69) | 0.881 |
| Placebo | 4.79 (0.49) | 4.67 (0.65) | 4.85 (0.36) | 4.78 (0.49) | 0 (0.57) | ||||||
| Orientation in place | Probiotic | 4.61 (0.62) | 0.136 | 4.87 (0.34) | 0.673 | 4.8 (0.76) | 0.557 | 4.96 (0.19)* | 0.943 | 0.32 (0.61) | 0.228 |
| Placebo | 4.79 (0.55) | 4.88 (0.42) | 4.94 (0.24) | 4.97 (0.18) | 0.19 (0.59) | ||||||
| Registration | Probiotic | 3 (0) | 0.348 | 3 (0) | 1.000 | 3 (0) | 1.000 | 2.96 (0.19) | 0.300 | –0.04 (0.19) | 0.167 |
| Placebo | 2.97 (0.17) | 3 (0) | 3 (0) | 3 (0) | 0.03 (0.18) | ||||||
| Serial-7 s | Probiotic | 2.16 (1.34) | 0.147 | 3.61 (1.76)** | 0.296 | 3.63 (1.52)*** | 0.771 | 3.32 (1.83)** | 0.658 | 1.14 (2.05) | 0.254 |
| Placebo | 1.88 (1.39) | 3.21 (1.69)*** | 3.67 (1.71)*** | 3.59 (1.72)*** | 1.69 (1.98) | ||||||
| Recall | Probiotic | 2.45 (0.81) | 0.902 | 2.61 (0.67) | 0.658 | 2.67 (0.66) | 0.208 | 2.79 (0.63) | 0.672 | 0.32 (0.77) | 0.817 |
| Placebo | 2.49 (0.76) | 2.67 (0.69) | 2.76 (0.71)* | 2.75 (0.62)* | 0.28 (0.63) | ||||||
| Naming | Probiotic | 2 (0) | 1.000 | 2 (0) | 1.000 | 2 (0) | 1.000 | 2 (0) | 1.000 | 0 (0) | 1.000 |
| Placebo | 2 (0) | 2 (0) | 2 (0) | 2 (0) | 0 (0) | ||||||
| Repetition | Probiotic | 0.84 (0.37) | 0.405 | 0.9 (0.3) | 0.766 | 0.97 (0.18) | 0.628 | 0.89 (0.32) | 0.546 | 0.07 (0.26) | 0.680 |
| Placebo | 0.91 (0.29) | 0.88 (0.33) | 0.94 (0.24) | 0.94 (0.25) | 0.03 (0.4) | ||||||
| Three-stage command | Probiotic | 2.94 (0.25) | 0.962 | 2.97 (0.18) | 0.982 | 2.9 (0.31) | 0.268 | 2.93 (0.26) | 0.492 | 0 (0.27) | 0.688 |
| Placebo | 2.94 (0.24) | 2.97 (0.17) | 2.97 (0.17) | 2.97 (0.18) | 0.03 (0.31) | ||||||
| Reading | Probiotic | 1 (0) | 1.000 | 0.97 (0.18) | 0.608 | 1 (0) | 1.000 | 1 (0) | 0.367 | 0 (0) | 0.367 |
| Placebo | 1 (0) | 0.94 (0.24) | 1 (0) | 0.97 (0.18) | –0.03 (0.18) | ||||||
| Writing | Probiotic | 0.74 (0.45) | 0.167 | 0.87 (0.34) | 0.036† | 0.97 (0.18)* | 0.628 | 0.89 (0.32) | 0.251 | 0.18 (0.55) | 0.445 |
| Placebo | 0.88 (0.33) | 1 (0) | 0.94 (0.24) | 0.97 (0.18) | 0.09 (0.39) | ||||||
| Construction | Probiotic | 0.97 (0.18) | 0.194 | 0.9 (0.3) | 0.603 | 0.97 (0.18) | 0.362 | 1 (0) | 0.190 | 0.04 (0.19) | 0.740 |
| Placebo | 0.91 (0.28) | 0.94 (0.24) | 0.91 (0.29) | 0.94 (0.25) | 0.06 (0.44) | ||||||
Data are indicated as mean (SD). p value shows inter-group difference (probiotics versus placebo) (Wilcoxon rank-sum test), †p < 0.05. Difference from baseline was analyzed by Wilcoxon signed rank Test), *p < 0.05, **p < 0.01, ***p < 0.001.