Extended data table 2. Safety parameters measured in all groups at baseline and after two weeks of treatment.
Placebo | Pasteurized Akk -1010 | Alive Akk -1010 | ||||
---|---|---|---|---|---|---|
Safety parameters | Baseline | Safety | Baseline | Safety | Baseline | Safety |
Systolic blood pressure (mm Hg) | 145,92 ± 13,94 | 134,92 ± 18,53 | 150,38 ± 12,52 | 134,85 ± 19,20* | 138,00 ± 17,97 | 138,21 ± 16,84 |
Diastolic blood pressure (mm Hg) | 94,92 ± 13,97 | 90,31 ± 9,89 | 101,92 ± 11,28 | 91,77 ± 17,19 | 95,57 ± 19,29 | 92,43 ± 12,49 |
C-reactive protein (mg/dl) | 5,23 ± 5,38 | 4,78 ± 3,14 | 7,77 ± 9,12 | 9,46 ± 11,33 | 4,07 ± 4,43 | 5,48 ± 5,860 |
White Blood cells (103/μl) | 6,00 ± 1,08 | 6,78 ± 1,48* | 6,47 ± 1,66 | 7,33 ± 1,54* | 6,74 ± 1,28 | 7,5 ± 1,53* |
Prothrombin time (sec) | 11,48 ± 0,69 | 11,35 ± 0,62 | 11,66 ± 0,89 | 11,5 ± 0,83 | 11,47 ± 0,67 | 11,38 ± 0,70 |
Alanine aminotransferase activity (U/L) | 23,38 ± 10,4 | 24,54 ± 10,94 | 47,62 ± 38,01 | 44,85 ± 35,59 | 33,43 ± 12,89 | 35,43 ±13,44 |
Aspartate aminotransferase activity (U/L) | 18,92 ± 5,78 | 18,77 ± 4,80 | 32,92 ± 31,45 | 35,23 ± 41,2 | 22,07 ± 7,08 | 23,64 ± 7,06 |
γ-Glutamyltransferase activity (U/L) | 25,92 ± 16,59 | 29,38 ± 24,77 | 50,85 ± 32,93 | 47,85 ± 27,82 | 39,64 ± 21,1 | 40,86 ± 20,08 |
Urea (mg/dl) | 33,69 ± 7,76 | 30,77 ± 6,76 | 30,38 ± 3,10 | 35,69 ± 13,38 | 32,21 ± 6,71 | 32,64 ± 7,33 |
Creatinine (mg/dl) | 0,84 ± 0,15 | 0,83 ± 0,17 | 0,82 ± 0,13 | 0,84 ± 0,14 | 0,86 ± 0,14 | 0,90 ± 0,11 |
Glomerular filtration rate (ml min-1 1,73m-2) | 84,15±16,09 | 86 ± 13,99 | 85,69 ± 14,13 | 82,92 ± 12,28 | 88,79 ± 15,84 | 82,14 ± 12,98 |
Creatine kinase activity (U/L) | 114,3 ± 59,88 | 100,9 ± 58,96 | 152 ± 81,47 | 123,1 ± 63,19 | 118,4 ± 50,57 | 165 ± 175,8 |
Lactate dehydrogenase activity (UI/L) | 177,4 ± 23,01 | 170,2 ± 21,46 | 193,9 ± 21,01 | 189,5 ± 39,34 | 190,9 ± 45,51 | 189,7 ± 32,22 |
This table includes all participants that proceeded to the safety visit: Placebo n=13, Pasteurized n=13, Alive n=14. Data are expressed as mean ± SD. Non-parametric two-tailed Wilcoxon matched-pairs signed ranks tests were performed to verify changes from baseline in each group.
Significant difference from baseline value (P < 0.05)