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Table 2 Frequencies of study compliance and adverse events stratified by baseline colonization site and randomized treatment group

From: Effect of Lactobacillus rhamnosus HN001 on carriage of Staphylococcus aureus: results of the impact of probiotics for reducing infections in veterans (IMPROVE) study

Compliance Extra-GI (N = 50) GI (N = 63)
Probiotic (N = 18)
n (%)
Placebo (N = 32)
n (%)
P-value Probiotic (N = 34)
n (%)
Placebo (N = 29)
n (%)
P-value
Withdrawal/Lost to Follow-Up 0 (0.0) 1 (3.1) 1.0000 0 (0.0) 0 (0.0) 1.0000
Non-Compliant 3 (16.7) 7 (21.9) 0.7189 9 (26.5) 9 (31.0) 0.6699
Other Probiotic Use 7 (38.9) 11 (34.4) 0.5788 11 (32.4) 10 (34.5) 0.8418
Adverse Events
 Fever 0 (0.0) 2 (6.3) 0.5105 1 (2.9) 1 (3.5) 1.0000
 Infection 0 (0.0) 1 (3.1) 1.0000 1 (2.9) 0 (0.0) 1.0000
 Nausea/Vomiting 3 (16.7) 5 (15.6) 1.0000 4 (11.8) 2 (6.9) 0.6782
 Constipation 4 (22.2) 2 (6.3) 0.1710 0 (0.0) 1 (3.5) 0.4603
 Cough/Cold/Congestion 1 (5.6) 5 (15.6) 0.3991 3 (8.8) 6 (20.7) 0.2804
 Headache 0 (0.0) 1 (3.1) 1.0000 1 (2.9) 1 (3.5) 1.0000
 Muscle Pain/Cramp/Spasm 3 (16.7) 5 (15.6) 1.0000 11 (32.4) 4 (13.8) 0.1371
 Upset Stomach/Heartburn 1 (5.6) 1 (3.1) 1.0000 1 (2.9) 1 (3.5) 1.0000
 Gas/Bloating 2 (11.1) 1 (3.1) 0.2914 1 (2.9) 1 (3.5) 1.0000
 Insomnia 0 (0.0) 0 (0.0) 1.0000 1 (2.9) 1 (3.5) 1.0000
 Unusual Stool (Loose/ Discolored/More Frequent) 2 (11.1) 8 (25.0) 0.2947 7 (20.6) 5 (17.2) 1.0000
 Bad Taste 0 (0.0) 2 (6.3) 0.5298 0 (0.0) 1 (3.5) 0.4603
 Cardiovascular Event 0 (0.0) 2 (6.3) 0.5298 0 (0.0) 0 (0.0) 1.0000
 Itchiness 0 (0.0) 0 (0.0) 1.0000 0 (0.0) 2 (6.9) 0.2079
 Swelling 1 (0.0) 1 (3.1) 1.0000 0 (0.0) 0 (0.0) 1.0000
  1. Abbreviations: GI gastrointestinal