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 |