Randomized Controlled Trial
Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Sep 7, 2014; 20(33): 11878-11885
Published online Sep 7, 2014. doi: 10.3748/wjg.v20.i33.11878
Table 1 Demographic description of the enrolled volunteers n (%)
Probiotic (n = 40)Placebo (n = 40)P value
Female20 (50)20 (50)
Male20 (50)20 (50)
Age (yr)33.7 ± 9.430.9 ± 10.30.164
Weight (kg)72.5 ± 12.971.5 ± 12.10.706
Height (cm)171.2 ± 8.7170.5 ± 10.30.766
BMI (kg/m²)24.7 ± 3.524.5 ± 2.70.743
Hispani or Latino4 (10)6 (16)
African American3 (7)1 (2)
White29 (73)32 (80)
Other4 (10)1 (2)
Alcohol use
None8 (20)14 (35)0.013
Occasionally28 (70)15 (38)
Weekly4 (10)11 (28)
Ex-smoker2 (5)4 (10)
n38 (95)36 (90)
Table 2 Bacterial counts
ProbioticP value (within group)PlaceboP value
Within groupBetween group
Total bacteria
Baseline10.89 ± 0.22-10.81 ± 0.23-0.067
End of antibiotic + probiotic/placebo10.58 ± 0.43< 0.00110.49 ± 0.38< 0.0010.177
End of probiotic/placebo10.75 ± 0.300.00310.77 ± 0.260.3990.735
End of follow-up10.87 ± 0.240.52710.79 ± 0.310.5680.221
Lactobacillus
Baseline7.40 ± 0.79-7.42 ± 1.56-0.391
End of antibiotic + probiotic/placebo7.13 ± 0.880.1046.91 ± 1.450.0320.642
End of probiotic/placebo7.42 ± 0.770.9447.07 ± 1.380.0300.331
End of follow-up7.16 ± 1.500.3756.96 ± 1.870.1490.851
Lactobacillus acidophilus ATCC 700396
Baseline1.27 ± 2.20-0.93 ± 1.73-0.446
End of antibiotic + probiotic/placebo2.39 ± 2.980.0521.21 ± 2.070.4070.035
End of probiotic/placebo2.15 ± 2.790.2450.79 ± 1.540.9330.011
End of follow-up1.60 ± 2.510.2862.13 ± 2.740.0210.498
Bifidobacterium
Baseline8.62 ± 1.60-7.97 ± 1.99-0.087
End of antibiotic + probiotic/placebo8.20 ± 1.080.0167.83 ± 1.780.3500.642
End of probiotic/placebo8.72 ± 0.790.7598.01 ± 2.130.8050.142
End of follow-up8.52 ± 1.600.4668.12 ± 1.570.4220.236
Bifidobacterium lactis
Baseline8.81 ± 0.50-8.82 ± 0.69-0.914
End of antibiotic + probiotic/placebo8.41 ± 1.480.0548.20 ± 0.64< 0.0010.008
End of probiotic/placebo8.79 ± 0.630.9048.42 ± 0.67< 0.0010.013
End of follow-up8.67 ± 0.490.2068.49 ± 0.74< 0.0010.185
Bacteroides
Baseline9.14 ± 0.56-8.97 ± 0.48-0.161
End of antibiotic + probiotic/placebo9.06 ± 0.870.9819.00 ± 0.610.6290.345
End of probiotic/placebo8.98 ± 0.690.0508.85 ± 0.630.1940.429
End of follow-up9.14 ± 0.630.9728.91 ± 0.540.4790.079
Enterobacteriaceae
Baseline6.92 ± 0.83-6.74 ± 1.33-0.734
End of antibiotic + probiotic/placebo7.80 ± 1.16< 0.0017.68 ± 1.07< 0.0010.531
End of probiotic/placebo6.88 ± 0.730.9446.87 ± 0.720.7320.947
End of follow-up6.89 ± 0.550.9566.75 ± 1.330.5530.770
Clostridium difficile
Baseline2.85 ± 1.44-2.90 ± 1.29-0.563
End of antibiotic + probiotic/placebo3.42 ± 2.300.2832.95 ± 2.540.6320.281
End of probiotic/placebo3.13 ± 1.420.5662.56 ± 1.760.1260.077
End of follow-up3.08 ± 1.440.7122.91 ± 1.680.4750.935
Clostridium group XIV
Baseline10.04 ± 0.24-9.92 ± 0.39-0.073
End of antibiotic + probiotic/placebo9.36 ± 0.72< 0.0019.36 ± 0.45< 0.0010.582
End of probiotic/placebo9.85 ± 0.32< 0.0019.74 ± 0.370.0040.146
End of follow-up9.94 ± 0.250.0469.75 ± 0.360.0060.011
Table 3 Gastrointestinal Symptom Rating Scale scores for the study participants
Probiotic
Placebo
(n = 40)P value(within group)(n = 40)P value
Within groupWithin group
Stomach ache or painBaseline1.10 ± 0.38-1.32 ± 0.73-0.1011
End of antibiotic1.82 ± 1.320.00211.80 ± 1.260.03210.9911
End of treatment1.48 ± 1.220.10311.45 ± 1.010.63210.8291
End of study1.38 ± 0.980.13111.48 ± 1.150.67110.7411
NauseaBaseline1.00 ± 0.00-1.23 ± 0.66-0.0221
End of antibiotic1.50 ± 1.260.02211.60 ± 1.150.08810.3601
End of treatment1.27 ± 0.930.05411.15 ± 0.360.60810.8281
End of study1.12 ± 0.79> 0.99911.15 ± 0.530.60810.1871
Rumbling in stomachBaseline1.55 ± 0.75-1.50 ± 0.75-0.7431
End of antibiotic1.95 ± 1.340.03811.80 ± 1.360.18710.2341
End of treatment1.73 ± 1.260.56511.42 ± 0.870.48810.2781
End of study1.50 ± 0.930.38811.35 ± 0.770.17910.2671
BloatedBaseline1.25 ± 0.44-1.30 ± 0.76-0.5471
End of antibiotic1.85 ± 1.480.01011.32 ± 0.760.93610.0711
End of treatment1.50 ± 0.960.19711.32 ± 0.80> 0.99910.2421
End of study1.50 ± 0.880.09611.40 ± 1.080.71910.2961
FlatulusBaseline1.57 ± 0.81-1.52 ± 0.78-0.8341
End of antibiotic2.00 ± 1.360.02911.62 ± 0.980.85710.2391
End of treatment1.70 ± 1.30> 0.99911.45 ± 0.990.33110.3031
End of study1.52 ± 1.130.29111.45 ± 0.850.49210.6891
DiarrheaBaseline1.18 ± 0.55-1.20 ± 0.79-0.5121
End of antibiotic1.92 ± 1.530.00111.73 ± 1.260.05010.6141
End of treatment1.45 ± 1.280.26011.20 ± 0.61> 0.99910.6701
End of study1.35 ± 1.050.38911.15 ± 0.700.89210.0941
Loose stoolsBaseline1.25 ± 0.63-1.25 ± 0.71-0.7931
End of antibiotic1.70 ± 1.070.00211.48 ± 0.750.10910.4921
End of treatment1.48 ± 0.990.24111.20 ± 0.460.78410.3221
End of study1.25 ± 0.440.82411.27 ± 0.75> 0.99910.5031
Bowel movementBaseline1.25 ± 0.67-1.40 ± 0.84-0.2911
End of antibiotic1.73 ± 1.200.03211.73 ± 1.060.11610.7391
End of treatment1.52 ± 1.130.20811.35 ± 0.770.81310.7121
End of study1.38 ± 1.100.71711.32 ± 0.860.56510.8161
Acid refluxBaseline1.55 ± 0.71-1.55 ± 0.64-0.8501
End of antibiotic1.60 ± 0.900.80511.55 ± 0.810.96010.8901
End of treatment1.52 ± 0.720.89411.35 ± 0.660.12910.2101
End of study1.27 ± 0.600.03411.35 ± 0.660.16210.4961
ConstipationBaseline1.27 ± 0.51-1.25 ± 0.59-0.5171
End of antibiotic1.52 ± 1.150.26611.65 ± 1.250.00710.6251
End of treatment1.42 ± 1.110.82211.30 ± 0.760.85710.6051
End of study1.60 ± 1.240.10811.65 ± 1.250.03410.7081
Overal GSRSBaseline1.272 ± 0.280-1.322 ± 0.319-0.4441
End of antibiotic1.60 ± 0.76< 0.00111.54 ± 0.580.00710.9691
End of treatment1.45 ± 0.790.50911.28 ± 0.330.19210.4811
End of study1.36 ± 0.700.74011.32 ± 0.570.26410.8641