Commercially available probiotic drinks containing Lactobacillus casei DN-114001 reduce antibiotic-associated diarrhea

Table 1 Basic data (mean ± SD or percentage) of patients in the first study

Variable	Actimel group (ward A5)	Controls (wards A6/A7)	P value
n	107	151
Age (yr)	70.8 ± 15.6	70.8 ± 16.5	NS
Male gender	48.6%	52.3%	NS
PST 0 or 1	52.3%	56.6%	NS
BMI	25.7 ± 4.2	26.1 ± 4.8	NS
Creatinine (mg/dL)	1.2 ± 0.8	1.1 ± 0.6	NS
Albumine (mg/dL)	3.5 ± 0.4	3.5 ± 0.4	NS
Diagnosis (site of infection/sepsis)	Pulmonary: 55.7% Genitourinary: 26.4% Biliary: 2.8% Sepsis: 5.7% Diverticulitis: 2.8% Dermal: 2.8% Misc.: 3.7%	Pulmonary: 50.0% Genitourinary: 22.0% Biliary: 8.0% Sepsis: 1.3% Diverticulitis: 2.7% Dermal: 4.0% Misc.: 12.0%	NS
Antibiotics	Ampicillin: 26.4% Cefuroxime: 23.5% Ceftriaxone: 12.2% Ciprofloxacin: 16.0% Clarithromycin: 12.2% Tazobactam: 3.8% Levofloxacin: 6.6% Moxifloxacin: 3.8% Metronidazole: 3.7% Clindamycin: 0.0% Cotrimoxazole: 0.9%	Ampicillin: 19.3% Cefuroxime: 18.7% Ceftriaxone: 10.7% Ciprofloxacin: 20.0% Clarithromycin: 6.7% Tazobactam: 2.7% Levofloxacin: 2.7% Moxifloxacin: 0.0% Metronidazole: 6.7% Clindamycin: 3.3% Cotrimoxazole: 4.9%	NS
Days of treatment	7.3 ± 4.2	6.1 ± 3.6	0.008

NS: No significance; BMI: Body mass index.

Table 2 Basic data (mean ± SD or percentage) of patients in the second study

Variable	Actimel group	Yakult group	P value
n	30	30
Age (yr)	69.7 ± 17.6	74.1 ± 17.5	NS
Male gender	63.3%	60.0%	NS
PST 0 or 1	70.0%	51.7%	NS
BMI	25.9 ± 4.2	25.1 ± 4.1	NS
Creatinine (mg/dL)	1.2 ± 0.5	1.1 ± 0.3	NS
Albumin (mg/dL)	3.4 ± 0.3	3.3 ± 0.3	NS
Diagnosis (aite of infection/aepsis)	Pulmonary: 30.0% Genitourinary: 50.0% Biliary: 3.3% Sepsis: 0.0% Diverticulitis: 0.0% Dermal: 13.3% Misc.: 3.3%	Pulmonary: 50.0% Genitourinary: 26.7% Biliary: 6.7% Sepsis: 3.3% Diverticulitis: 3.3% Dermal: 6.7% Misc.: 3.3%	NS
Antibiotics	Ampicillin: 20.0% Cefuroxime: 20.0% Ceftriaxone: 20.0% Ciprofloxacin: 0.0% Clarithromycin: 10.0% Tazobactam: 0.0% Levofloxacin: 20.0% Moxifloxacin: 0.0% Cotrimoxazole: 3.3% Penicillin: 13.3%	Ampicillin: 36.7% Cefuroxime: 10.0% Ceftriaxone: 10.0% Ciprofloxacin: 3.3% Clarithromycin:16.7% Tazobactam: 10.0% Levofloxacin: 20.0% Moxifloxacin: 3.3% Cotrimoxazole: 6.7% Penicillin: 0.0%	NS
Days of treatment	6.0 ± 3.1	6.6 ± 3.7	NS
Concurrent PPI treatment	23.3%	50.0%	0.06
Antibiotic treatment in history	3.3%	10.0%	NS

NS: No significance; BMI: Body mass index.

Table 3 Endpoint data (mean ± SD or percentage) of the first study

Parameter	Actimel group (ward A5)	Controls (wards A6/A7)	P value
Hospital stay (d)	11.2 ± 6.8	12.2 ± 8.3	NS
Diarrhea	6.5%	28.4%	< 0.001
Duration of diarrhea (d)	1.7 ± 1.1	3.1 ± 2.1	0.015

NS: No significance.

Table 4 Differences in patients (mean ± SD or percentage) with and without diarrhea in the first study

Parameter	Diarrhea	No diarrhea	P value
n	49	206
Age (yr)	74.9 ± 13.3	69.6 ± 16.5	0.028
Gender	M: 20.0%F: 18.4%	M: 80.0%F: 81.6%	NS
Hospital stay (d)	15.0 ± 10.1	11.1 ± 6.9	0.007
Creatinine (mg/dL)	1.5 ± 0.8	1.1 ± 0.6	< 0.001
Albumine (mg/dL)	3.2 ± 0.2	3.4 ± 0.3	0.04
BMI	25.3 ± 4.7	26.1 ± 4.5	NS

NS: No significance; BMI: Body mass index.

Table 5 Endpoint data (mean ± SD or percentage) of the second study

Parameter	Actimel group	Yakult group	P value
Hospital stay (d)	10.8 ± 7.7	11.8 ± 7.8	NS
Diarrhea	6.7%	33.3%	0.021
Duration of diarrhea (d)	2.5 ± 0.7	4.4 ± 2.5	NS
CDAD	0.0%	10.0%	NS

NS: No significance; CDAD: Clostridium difficile-associated diarrhea.

Table 6 Differences in patients (mean ± SD or percentage) with and without diarrhea in the second study

Parameter	Diarrhea	No diarrhea	P value
n	12	48
Age (yr)	80.3 ± 13.4	69.8 ± 18	0.019
Gender	M: 21.6%F:17.4%	M: 78.4%F: 82.6%	NS
Hospital stay (d)	19.3 ± 10.9	9.3 ± 5.2	< 0.001
Creatinine (mg/dL)	1.2 ± 0.4	1.1 ± 0.4	NS
Albumine (mg/dL)	3.3 ± 0.5	3.6 ± 0.4	< 0.001
BMI	24.0 ± 4.0	25.9 ± 4.1	NS
Concurrent PPI treat.	75.0%	27.1%	0.005
Antibiotic treatment in history	33.3%	0.0%	0.001

NS: No significance; BMI: Body mass index.