TABLE 2.
Effect of treatments on primary and secondary outcomes.
| Outcome | Treatment | Outcome score, mean (SD), n | Mean difference at week 8 (95% CI; p)* | Cohen’s d (95% CI) | |
| Baseline | Week-8 | ||||
| POMS 2-SF TMD | Placebo | 11.6 (12.1), 28 | 10.2 (16.0), 25 | Reference | |
| Prebiotic diet | 10.9 (10.3), 28 | 3.00 (8.77), 22 | −6.97 (-13.6, -0.345; p = 0.039) | −0.60 (−1.18, −0.03) | |
| Probiotic | 13.5 (12.3), 30 | 7.22 (10.3), 23 | −2.17 (−8.72, 4.38; p = 0.51) | −0.19 (−0.75, 0.38) | |
| Synbiotic | 11.5 (11.7), 32 | 10.3 (17.2), 23 | −0.331 (−6.81, 6.15; p = 0.92) | −0.03 (−0.59, 0.53) | |
| PSS total | Placebo | 13.5 (5.88), 28 | 13.0 (7.17), 25 | Reference | |
| Prebiotic diet | 12.5 (4.58), 28 | 9.50 (4.46), 22 | −3.20 (−5.82, −0.575; p = 0.017) | −0.61 (−1.11, −0.11) | |
| Probiotic | 12.8 (4.49), 31 | 10.6 (4.62), 24 | −1.65 (−4.22, 0.924; p = 0.21) | −0.31 (−0.80, 0.18) | |
| Synbiotic | 12.7 (6.05), 32 | 10.3 (5.89), 23 | −1.89 (−4.49, 0.710; p = 0.15) | −0.36 (−0.86, 0.14) | |
| WHO-5 total1 | Placebo | 13.1 (4.57), 27 | 14.6 (5.10), 25 | Reference | |
| Prebiotic diet | 13.8 (3.80), 28 | 15.9 (4.99), 22 | 1.02 (–1.21, 3.25; p = 0.37) | 0.24 (−0.28, 0.76) | |
| Probiotic | 12.0 (4.51), 31 | 14.1 (4.25), 24 | 0.141 (−2.04, 2.32; p = 0.90) | 0.03 (−0.48, 0.55) | |
| Synbiotic | 13.9 (4.05), 32 | 14.3 (4.10), 23 | −0.498 (−2.70, 1.70; p = 0.65) | −0.12 (−0.63, 0.40) | |
| LSEQ average1 | Placebo | 4.85 (1.05), 27 | 5.08 (1.09), 25 | Reference | |
| Prebiotic diet | 4.67 (0.942), 28 | 5.74 (1.17), 22 | 0.770 (0.119, 1.42; p = 0.021) | 0.73 (0.11, 1.34) | |
| Probiotic | 4.56 (0.899), 31 | 5.14 (0.94), 24 | 0.237 (−0.475, 0.879; p = 0.47) | 0.22 (−0.38, 0.83) | |
| Synbiotic | 4.72 (1.30), 32 | 5.18 (1.46), 23 | 0.180 (−0.462, 0.822; p = 0.58) | 0.17 (−0.44, 0.78) | |
| Outcome1 | Treatment | Outcome score, mean (SD), n | OR (95% CI; p)* | ||
| Baseline | Week-8 | ||||
| BAI total | Placebo | 5.29 (3.10), 28 | 5.76 (3.89), 25 | Reference | |
| Prebiotic diet | 3.57 (3.17), 28 | 2.41 (1.99), 22 | 0.290 (0.102, 0.801; p = 0.018) | ||
| Probiotic | 4.87 (3.07), 31 | 3.29 (2.56), 24 | 0.394 (0.142, 1.07; p = 0.069) | ||
| Synbiotic | 4.00 (3.15), 32 | 4.04 (4.35), 23 | 0.480 (0.163, 1.39; p = 0.18) | ||
| BDI total | Placebo | 5.57 (4.71), 28 | 4.24 (7.26), 25 | Reference | |
| Prebiotic diet | 5.96 (4.75), 28 | 2.59 (2.65), 22 | 0.568 (0.192, 1.65; p = 0.30) | ||
| Probiotic | 5.10 (3.88), 31 | 3.25 (2.92), 24 | 0.938 (0.343, 2.58; p = 0.90) | ||
| Synbiotic | 5.94 (4.57), 32 | 5.04 (5.80), 23 | 1.18 (0.410, 3.41; p = 0.76) | ||
| SF-36 fatigue2 | Placebo | 49.3 (18.5), 27 | 53.6 (22.8), 25 | Reference | |
| Prebiotic diet | 50.4 (15.3), 28 | 59.3 (19.1), 22 | 1.91 (0.686, 5.41; p = 0.22) | ||
| Probiotic | 43.5 (17.2), 31 | 52.1 (18.5), 24 | 1.60 (0.602, 4.26; p = 0.35) | ||
| Synbiotic | 48.3 (20.3), 32 | 52.2 (21.2), 23 | 1.20 (0.436, 3.31; p = 0.23) | ||
| SF-36 wellbeing2 | Placebo | 70.8 (13.0), 27 | 72.6 (14.7), 25 | Reference | |
| Prebiotic diet | 76.9 (10.3), 28 | 79.3 (8.96), 22 | 1.61 (0.573, 4.54; p = 0.37) | ||
| Probiotic | 69.3 (11.9), 31 | 77.8 (9.06), 24 | 2.90 (1.10, 7.77; p = 0.032) | ||
| Synbiotic | 71.5 (12.5), 32 | 74.1 (15.5), 23 | 1.49 (0.524, 4.23; p = 0.46) | ||
*Model estimates adjusted for baseline outcome score.
1Outcomes modelled as ordinal – odds ratios represent fold-change in odds of poorer outcomes (e.g., more severe anxiety) for BAI and BDI scales, and odds of better outcomes for SF-36 fatigue and wellbeing subscales.
2Higher values indicate better outcomes. OR, odds ratio; POMS 2-SF, Profile of Mood States 2 – Short Form; BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory-II; PSS, Perceived Stress Scale; SF-36, Short Form Survey-36.