Table 2.
Reported clinical outcomes in RCTs evaluating probiotics in critically ill patients
| Study | Mortality | Infections | Length of stay | Diarrhea | |||||
|---|---|---|---|---|---|---|---|---|---|
| Intervention | Control | Intervention | Control | Intervention | Control | Intervention | Control | ||
| 1 | Tempe 1983 [30] | 3/20 (15) | 3/20 (15) | NR | NR | NR | NR | Diarrhea days 34/389 (9) | Diarrhea days 63/373 (17) |
| 2 | Schlotterer 1987 [31] | NR | NR | NR | NR | NR | NR | Diarrhea days 3/150 (2) | Diarrhea days 19/143 (13) |
| 3 | Heimburger 1994 [32] | NR | NR | NR | NR | NR | NR | Diarrhea 5/16 (31) | Diarrhea 2/18 (11) |
| 4 | Bleichner 1997 [33] | NR | NR | NR | NR | NR | NR | Diarrhea 18/64 (28) Days w/diarrhea 91/648 (14) |
Diarrhea 24/64 (38) Days w/diarrhea 134/683 (20) |
| 5 | Kecskes 2003 [34] | Hospital 1/22 (5) | Hospital 2/23 (9) | Septic compl 1/22 (5) | Septic compl 7/23 (30) | Hospital 13.7 ± 8.7 | Hospital 21.4 ± 17.9 | NR | NR |
| 6 | Jain 2004 [36] | Hospital 22/45 (49) | Hospital 20/45 (45) | Septic compl 33/45 (73) | Septic compl 26/45 (58) | Hospital 24.0 ± 31.5 ICU 11.9 ± 13.1 |
Hospital 18.7 ± 13.5 ICU 9.0 ± 8.9 |
NR | NR |
| 7 | Lu 2004 [35] | Hospital 2/20 (10) | Hospital 1/20 (5) | Infectious compl 8/20 (40) | Infectious compl 11/20 (55) | NR | NR | NR | NR |
| 8 | Klarin 2005 [37] | Hospital 2/8 (25) ICU 1/8 (12) |
Hospital 2/7 (29) ICU 2/7 (29) |
NR | NR | Hospital 48.3 ± 30.4 ICU 14.2 ± 10.6 |
Hospital 34.3 ± 15.4 ICU 16.3 ± 15.7 |
NR | NR |
| 9 | McNaught 2005 [38] | 18/52 (35) | 18/51 (35) | Septic morbidity 21/52 (40) | Septic morbidity 22/51 (43) | ICU 5 (2–9) | ICU 4 (2–7) | NR | NR |
| 10 | Kotzampassi 2006 [39] | ICU 5/35 (14) | ICU 9/30 (30) | Infections 22/35 (63) VAP 19/35 (54) Septic compl 17/35 (49) Central venous line infections 13/35 (37) Wound infections 6/35 (17) UTI 6/35 (17) |
Infections 27/30 (90) VAP 24/30 (80) Septic compl 23/30 (77) Central venous line infections 20/30 (66) Wound infections 8/30 (26) UTI 13/30 (43) |
ICU 27.7 ± 15.2 | ICU 41.3 ± 20.5 | Diarrhea 5/35 (14) | Diarrhea 10/30 (30) |
| 11 | Alberda 2007 [40] | ICU 1/10 (10) | ICU 1/9 (11) | NR | NR | NR | NR | Diarrhea 1/10 (14) | Diarrhea 2/9 (23) |
| 12 | Li 2007 [41] | NR | NR | Infections 8/14 (58) | Infections 10/11 (91) | Hospital 42 ± 5.0 | Hospital 49 ± 6.8 | NR | NR |
| 13 | Olah 2007 [42] | Hospital 2/33 (6) | Hospital 6/29 (21) | Infections 9/33 (27) Septic compl 7/33 (12) Pancreatic abscess 2/33 (6) Infected pancreatic necrosis 2/33 (6) UTI 3/33 (9) |
Infections 15/29 (52) Septic compl 17/29 (28) Pancreatic abscess 2/29 (7) Infected pancreatic necrosis 6/29 (21) UTI 3/33 (9) |
Hospital 14.9 ± 3.3 | Hospital 19.7 ± 4.5 | NR | NR |
| 14 | Forestier 2008 [44] | NR | NR | VAP 19/102 (19) | VAP 21/106 (20) | ICU 22.5 ± 20.6 | ICU 19.7 ± 16.7 | NR | NR |
| 15 | Besselink 2008 [43] | 24/152 (16) | 9/144 (6) | Infections 46/152 (30) VAP 24/152 (16) Bacteremia 33/152 (22) Infected necrosis 21/152 (14) Urosepsis 1/52 (2) |
Infections 41/144 (28) VAP 16/144 (11) Bacteremia 22/144 (15) Infected necrosis 14/144 (10) Urosepsis 2/144 (1) |
Hospital 28.9 ± 41.5 ICU 6.6 ± 17 |
Hospital 23.5 ± 25.9 ICU 3.0 ± 9.3 |
Diarrhea 25/152 (16) | Diarrhea 28/144 (19) |
| 16 | Klarin 2008 [45] | Hospital 3/22 (5) ICU 2/22 (9) |
Hospital 2/22 (0) ICU 2/22 (9) |
C. difficile + fecal samples 0/71 | C. difficile + fecal samples 4/80 | Hospital 25.8 ± 19.4 ICU 8.0 ± 5.4 |
Hospital 50.3 ± 75.2 ICU 11.6 ± 14 |
NR | NR |
| 17 | Knight 2009 [46] | Hospital 35/130 (27) ICU 28/130 (22) |
Hospital 42/129 (33) ICU 34/129 (26) |
VAP 12/130 (9) | VAP 17/129 (13) | ICU 6 (3–11) | ICU 7 (3–14) | Diarrhea 7/130 (5) | Diarrhea 9/129 (7) |
| 18 | Barraud 2010 [47] | ICU 21/87 (24) 28 days 22/87 (25) 90 days 27/87 (31) |
ICU 21/80 (26) 28 days 19/80 (24) 90 days 24/80 (30) |
All infections 30/87 (34) Infection > 96 h 26/87 (30) VAP 23/87 (26) Catheter-related BSI 3/87 (4) UTI 4/87 (5) |
All infections 30/80 (38) Infection > 96 h 29/80 (36) VAP 15/80 (19) Catheter-related BSI 11/80 (14) UTI 4/89 (5) |
Hospital 26.6 ± 22.3 ICU 18.7 ± 12.4 |
Hospital 28.9 ± 26.4 ICU 20.2 ± 20.8 |
Diarrhea 48/87 (55) | Diarrhea 42/80 (53) |
| 19 | Morrow 2010 [10] | 12/68 (18) | 15/70 (21) | VAP 13/73 (18) | VAP 28/73 (38) | Hospital 21.4 ± 14.9 ICU 14.8 ± 11.8 |
Hospital 21.7 ± 17.4 ICU 14.6 ± 11.6 |
Non C. difficile diarrhea 42/68 (62) C. difficile diarrhea 4/68 (6) |
Non C. difficile diarrhea 44/70 (63) C. difficile diarrhea 13/70 (19) |
| 20 | Frohmader 2010 [48] | 5/20 (25) | 3/25 (12) | NR | NR | ICU 7.3 ± 5.7 | ICU 8.1 ± 4 | Diarrhea episodes/pt/day 0.53 ± 0.54 | Diarrhea episodes/pt/day 1.05 ± 1.08 |
| 21 | Ferrie 2011 [49] | Hospital 2/18 (11) 6 months 7/18 (39) |
Hospital 2/18 (11) 6 months 5/18 (28) |
Infections 14/18 (78) | Infections 16/18 (89) | Hospital 54.50 ± 31.26 ICU 32.04 ± 24.46 |
Hospital 59.04 ± 33.92 ICU 29.75 ± 18.81 |
Duration of diarrhea 3.83 ± 2.39 Loose stools/day 1.58 ± 0.88 |
Duration of diarrhea 2.56 ± 1.85 Loose stools/day 1.10 ± 0.79 |
| 22 | Sharma 2011 [50] | Hospital 2/24 (8) | Hospital 2/26 (8) | NR | NR | Hospital 13.23 ± 18.19 ICU 4.94 ± 9.54 |
Hospital 9.69 ± 9.69 ICU 4.0 ± 5.86 |
NR | NR |
| 23 | Tan 2011 [51] | 28 days 3/26 (12) | 28 days 5/26 (19) | Infections 9/26 (35) VAP 7/26 (27) |
Infections 15/26 (58) VAP 13/26 (50) |
ICU 6.8 ± 3.8 | ICU 10.7 ± 7.3 | NR | NR |
| 24 | Cui 2013 [20] | Hospital 1/23 (4) | Hospital 1/25 (4) | N/A | N/A | Hospital 10.4 ± 3.9 (23) | Hospital 13.4 ± 5.2 (25) | NR | NR |
| 25 | Tan 2013 [21] | 28 days 23/26 (12) | 28 days 5/26 (19) | NR | NR | ICU 6.8 ± 3.8 (26) | ICU 10.7 ± 7.3 (26) | NR | NR |
| 26 | Wang 2013 [22] | Unspecified 1/62 (8.1) | Unspecified 3/61 (9.8) | Pancreatic sepsis 8/62 (13) MODS 7/62 (11.3) |
Pancreatic sepsis 13/61 (21) MODS 15/61 (25) |
NR | NR | NR | NR |
| 27 | Lopez de Toro 2014 [23] | Hospital 19/46 (41) ICU 15/46 (33) |
Hospital 18/43 (42) ICU 14/43 (33) |
Hospital acquired infections 9/46 (20) | Hospital acquired infections 13/43 (30) | Hospital 18.5 (10–36) ICU 9 (3–19) |
Hospital 24.5 (10–38) ICU 8 (2.5–16.5) |
NR | NR |
| 28 | Sanaie 2014 [24] | 28 days 2/20 (10) | 28 days 5/20 (25) | Bacteremia 2/20(10) | Bacteremia 5/20(25) | ICU 13.85 ± 6.96 | ICU 14.16 ± 5.97 | NR | NR |
| 29 | Rongrungruang 2015 [25] | 28 days 18/75 (24) 90 day 25/75 (33) |
28 days 17/75 (22.7) 90 day 26/75 (34.7) |
VAP 18/75 (24) | VAP 22/75 (29.3) | Hospital 20 (2–106) ICU 30.5 (4–98) |
Hospital 19 (3–171) ICU 19 (5–30) |
Diarrhea 19/75 (25.3) | Diarrhea 14/75 (18.7) |
| 30 | Zeng 2016 [26] | Hospital 26/118 (22) ICU 15/118 (12.7) |
Hospital 25/117 (21.4) ICU 9/117 (7.7) |
VAP 43/118 (36.4) | VAP 59/117 (50.4) | Hospital 13.5 ± 12.4 ICU 18 (14–32) |
Hospital 10.6 ± 10.2 ICU 22 (11–56) |
NR | NR |
BSI blood stream infection, ICU intensive care unit, NR not reported, RCT randomized control trial, UTI urinary tract infection, VAP ventilator associated pneumonia, N/A non-attributable, compl complications, MODS Multiple Organ Dysfunction Syndrome, Days w/ diarrhea - days with diarrhea