Table 1.
Group | Patients: probiotics (n = 44) and placebo (n = 36) | Controls (n = 51) | ||||
---|---|---|---|---|---|---|
Baseline | 3 months of intervention | End of intervention (6 months) | End of observation (12 months) | |||
Age (years) | Probiotics | 60 (54; 64)* | – | – | – | 53 (44; 60) |
Placebo | 56 (50; 63) | – | – | – | ||
Sex (M/F) | Probiotics | 32/12* | – | – | – | 22/29 |
Placebo | 26/10* | – | – | – | ||
Aetiology (Alc/HCV/others) | Probiotics | 24/8/12 | – | – | – | – |
Placebo | 20/5/11 | – | – | – | ||
CPG (A/B+C) | Probiotics | 28/16† | 31/13† , § | 29/15† , § | 24/20† | – |
Placebo | 33/3† , § | 33/3† , § | 33/3† , § | 33/3† , § | ||
CPS | Probiotics | 6 (5; 7)† | 5 (5; 7)† | 6 (5; 7)† | 7 (5; 7)† | – |
Placebo | 5 (5; 6) | 5 (5; 6) | 5 (5; 6) | 5 (5; 6) | ||
MELD | Probiotics | 12 (9; 15)† | 11 (9; 14)† | 11 (9; 15)† | 12 (9; 14)† | – |
Placebo | 9 (8; 13) | 9 (8; 11) | 9 (8; 12) | 8 (7; 11) | ||
ALT (U/L) | Probiotics | 36.5 (27.0; 51.25)* | 34.5 (27.5; 48.5) | 38.5 (25.8; 52.3) | 36.0 (26.0; 53.5) | 21.0 (16.5; 27.5) |
Placebo | 32.5 (20.75; 46.25)* | 30.0 (22.0; 43.3) | 29.5 (22.0; 49.8) | 30.0 (22.0; 42.5) | ||
AST (U/L) | Probiotics | 49.0 (37.75; 69.5)* | 44.5 (36.0; 59.0) | 53.5 (36.8; 70.0)† | 49.5 (37.5; 68.3) | 22.0 (19.0; 27.0) |
Placebo | 42.5 (32.5; 56.5)* | 40.5 (31.5; 58.0) | 37.5 (30.8; 59.0) | 45.0 (29.8; 63.3) | ||
Crea (mg/dL) | Probiotics | 0.85 (0.73; 0.96) | 0.83 (0.73; 0.94) | 0.85 (0.74; 1.01) | 0.85 (0.75; 0.98) | 0.86 (0.77; 1.0) |
Placebo | 0.81 (0.72; 0.94) | 0.78 (0.70; 0.98) | 0.80 (0.70; 0.88) | 0.83 (0.71; 0.92) | ||
Alb (g/dL) | Probiotics | 4.0 (3.3; 4.5)* , ‡ | 4.0 (3.4; 4.5)† | 4.0 (3.4; 4.5)† | 3.9 (3.3; 4.4)† | 4.5 (4.4; 4.8) |
Placebo | 4.3 (4.1; 4.7) | 4.4 (4.0; 4.6) | 4.3 (4.0; 4.4) | 4.3 (3.9; 4.5) | ||
Bili (mg/dL) | Probiotics | 1.38 (0.78; 2.41)* | 1.29 (0.74; 2.25) | 1.32 (0.77; 2.69) | 1.46 (0.88; 2.41)† | 0.50 (0.38; 0.61) |
Placebo | 1.11 (0.63; 1.42)* | 0.97 (0.74; 1.38) | 0.95 (0.68; 1.48) | 1.00 (0.64; 1.59) | ||
INR | Probiotics | 1.27 (1.14; 1.43)* | 1.27 (1.18; 1.39)† | 1.28 (1.16; 1.48)† | 1.30 (1.14; 1.45)† | 1.01 (0.98; 1.05) |
Placebo | 1.20 (1.12; 1.27)* | 1.18 (1.09; 1.32) | 1.18 (1.11; 1.25) | 1.14 (1.09; 1.25) |
Alc, alcoholic cirrhosis; HCV, hepatitis C virus‐associated cirrhosis; CPG, Child–Pugh grade; CPS, Child–Pugh score; MELD, model of end‐stage liver disease; ALT, alanine aminotransferase, AST, aspartate transaminase; Crea, creatinine; Alb, albumin; Bili, total bilirubin; INR, prothrombin time international normalised ratio.
Data are given in median (Q1; Q3).
*Significant difference compared to control group; †significant difference between test groups; ‡significant change over time; §to expected distribution; significance level 0.05.