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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