Table 3.
Comparative visual analogue scale (VAS) scores evaluated in antibiotic-associated diarrhea (AAD) at baseline and EOT in pediatric (Test-PS and Placebo-PS) and adolescent and adult group (Test-AA and Placebo-AA) (±SD). In both groups, test arms received Alkalihalobacillus clausii 088AE. Symptoms considered were abdominal pain, diarrhea, bloating and flatulence, nausea and vomiting, perception of mental well-being and influence daily life. Intragroup [MD = baseline-EOT] and intergroup mean differences [in pediatric (MD = Placebo-PS – Test-PS) and adolescent and adult group (MD = Placebo-AA – Test-AA)] for all the symptoms was analyzed through ANOVA and 95% confidence interval (CI) estimation at EOT and mean.
| Parameters | Arms | Baseline | EOT | Mean change | p (<0.05) | 95% CI |
|---|---|---|---|---|---|---|
| Abdominal pain | Placebo-PS | 6.53 ± 0.51 | 5.93 ± 1.31 | -0.60 ± 0.26 | <0.0001 | -1.12,-0.09 |
| Test-PS | 7.40 ± 0.67 | 0.73 ± 0.83 | -6.67 ± 0.19 | -7.06,-6.28 | ||
| Between groups (Placebo-PS – Test-PS) | -6.07 ± 0.05 | -5.76,-4.63 (at EOT) 5.95, 6.18 (at mean) | ||||
| Placebo-AA | 4.50 ± 1.33 | 2.30 ± 0.58 | -2.20 ± 0.26 | <0.0001 | -2.73,-1.67 | |
| Test-AA | 4.67 ± 1.62 | 1.27 ± 0.51 | -3.40 ± 0.31 | -4.02,-2.77 | ||
| Between groups (Placebo-AA – Test-AA) | -1.20 ± 0.07 | -1.31, -0.75 (at EOT) -1.34,-1.05 (at mean) | ||||
| Diarrhea (bowel movement) | Placebo-PS | 6.40 ± 0.62 | 5.80 ± 1.49 | -0.60 ± 0.29 | <0.0001 | -1.18,-0.01 |
| Test-PS | 6.96 ± 0.72 | 0.76 ± 1.04 | -6.20 ± 0.23 | -6.66,-5.73 | ||
| Between groups (Placebo-PS – Test-PS) | -5.60 ± 0.06 | -5.70,-4.37 (at EOT) 5.46, 5.73 (at mean) | ||||
| Placebo-AA | 6.76 ± 0.93 | 3.20 ± 2.21 | -3.56 ± 0.43 | <0.0001 | -4.43,-2.68 | |
| Test-AA | 6.80 ± 1.49 | 1.76 ± 2.25 | -5.04 ± 0.49 | -6.02,-4.05 | ||
| Between groups (Placebo-AA – Test-AA) | -1.48 ± 0.12 | -2.59,-0.28 (at EOT) 1.24,1.72 (at mean) | ||||
| Bloating and flatulence | Placebo-PS | 6.23 ± 0.62 | 5.63 ± 1.24 | -0.60 ± 0.25 | <0.0001 | -1.10,-0.09 |
| Test-PS | 6.50 ± 0.63 | 0.40 ± 0.62 | -6.10 ± 0.16 | -6.42,-5.77 | ||
| Between groups (Placebo-PS – Test-PS) | -5.50 ± 0.05 | -5.73,-4.72 (at EOT) -5.61,-5.39 (at mean) | ||||
| Placebo-AA | 3.23 ± 1.16 | 1.43 ± 1.04 | -1.80 ± 0.28 | <0.0001 | -2.36,-1.23 | |
| Test-AA | 3.03 ± 0.92 | 0.90 ± 0.80 | -2.13 ± 0.22 | -2.57,-1.68 | ||
| Between groups (Placebo-AA – Test-AA) | -0.33 ± 0.06 | -1.01,-0.05 (at EOT) -0.46,-0.19 (at mean) | ||||
| Nausea and vomiting | Placebo-PS | 6.16 ± 0.64 | 5.40 ± 1.54 | -0.76 ± 0.30 | <0.0001 | -1.36,-0.15 |
| Test-PS | 6.30 ± 0.65 | 0.03 ± 0.18 | -6.27 ± 0.12 | -6.51,-6.02 | ||
| Between groups (Placebo-PS – Test-PS) | -5.51 ± 0.05 | -5.93,-4.80 (at EOT) -5.63,-5.39 (at mean) | ||||
| Placebo-AA | 2.56 ± 1.30 | 1.16 ± 0.98 | -1.40 ± 0.29 | <0.0001 | -1.99,-0.80 | |
| Test-AA | 2.56 ± 1.50 | 0.63 ± 0.89 | -1.93 ± 0.31 | -2.56,-1.29 | ||
| Between groups (Placebo-AA – Test-AA) | -0.53 ± 0.07 | -1.01,-0.04 (at EOT) -0.68,-0.37 (at mean) | ||||
| Perception of mental well-being | Placebo-PS | 6.06 ± 0.78 | 5.33 ± 1.34 | -0.73 ± 0.28 | <0.0001 | -1.29,-0.16 |
| Test-PS | 6.60 ± 1.89 | 0.06 ± 0.25 | -6.54 ± 0.35 | -7.23,-5.84 | ||
| Between groups (Placebo-PS – Test-PS) | -5.81 ± 0.08 | -5.76,-4.77 (at EOT) -5.97,-5.64 (at mean) | ||||
| Placebo-AA | 3.20 ± 0.92 | 1.43 ± 1.16 | -1.77 ± 0.27 | <0.0001 | -2.31,-1.22 | |
| Test-AA | 3.10 ± 1.06 | 0.83 ± 0.95 | -2.27 ± 0.26 | -2.79,-1.74 | ||
| Between groups (Placebo-AA – Test-AA) | -0.50 ± 0.06 | -1.14,-0.05 (at EOT) -0.63,-0.36 (at mean) | ||||
| Influence daily life | Placebo-PS | 6.30 ± 0.87 | 5.13 ± 1.27 | -1.17 ± 0.28 | <0.0001 | -1.73,-0.60 |
| Test-PS | 6.67 ± 0.92 | 0.30 ± 0.46 | -6.37 ± 0.18 | -6.74,-5.99 | ||
| Between groups (Placebo-PS – Test-PS) | -5.20 ± 0.06 | -5.32,-4.33 (at EOT) -5.32,-5.07 (at mean) | ||||
| Placebo-AA | 5.50 ± 1.16 | 3.53 ± 2.40 | -1.97 ± 0.48 | <0.0001 | -2.94,-0.99 | |
| Test-AA | 5.56 ± 1.30 | 2.10 ± 2.38 | -3.46 ± 0.49 | -4.45,-2.46 | ||
| Between groups (Placebo-AA – Test-AA) | -1.49 ± 0.12 | -2.66,-0.19 (at EOT) -1.74,-1.23 (at mean) |