Table 3.
(a) Incidence and Severity of Respiratory Tract Infections in Each Group | |||||||||
K15 (n = 20) | Placebo (n = 18) | p | |||||||
Incidence of respiratory tract infections, n (%) | 20 (100) | 16 (88.9) | 0.2176 | ||||||
Total days of respiratory tract infections, median [range] | 41.5 [2–129] | 35.5 [0–334] | 0.8378 | ||||||
Respiratory syncytial virus infection, n (%) | 1 (5.0) | 1 (5.6) | >0.9999 | ||||||
Hospital visit, n (%) | 19 (95.0) | 16 (88.9) | 0.5946 | ||||||
Total days of hospital visits, median [range] | 4.5 [0–17] | 4.5 [0–29] | 0.9066 | ||||||
Hospital admission with respiratory tract infection, n (%) | 0 (0.0) | 2 (11.1) | 0.2065 | ||||||
Oxygen use, n (%) | 0 (0.0) | 2 (11.1) | 0.2065 | ||||||
Mechanical ventilation, n (%) | 0 (0.0) | 2 (11.1) | 0.2065 | ||||||
(b) The changes in serum IgG, IgA, and IgM levels between, before and after the study period in each group | |||||||||
IgG, mg/dL (mean ± SD) | IgA, mg/dL (mean ± SD) | IgM, mg/dL (mean ± SD) | |||||||
Before | After | p | Before | After | p | Before | After | p | |
K15 (n = 20) |
383 ± 189 | 566 ± 129 | 0.4882 | <10.0 ± 0.0 | 27.6 ± 13.4 | 0.2509 | 23.7 ± 12.4 | 81.5 ± 29.3 | 0.5094 |
Placebo (n = 18) |
371 ± 209 | 602 ± 184 | <10.0 ± 0.0 | 35.0 ± 24.6 | 21.4 ± 5.9 | 67.7 ± 26.7 | |||
(c) Adverse effects in each group during the study period | |||||||||
K15 (n = 20) | Placebo (n = 18) | p | |||||||
Gastrointestinal tract symptoms, n (%) | 13 (65.0) | 12 (66.7) | >0.9999 | ||||||
Total days with gastrointestinal tract symptoms, mean ± SD | 12.4 ± 25.5 | 7.8 ± 17.9 | 0.8474 | ||||||
Skin symptoms, n (%) | 11 (55.0) | 6 (33.3) | 0.2097 | ||||||
Total days with skin symptoms, mean ± SD | 4.2 ± 7.8 | 3.1 ± 6.3 | 0.6000 |
IgG: immunoglobulin G; IgA: immunoglobulin A; IgM: immunoglobulin M. SD: standard deviation.