Table 5.
Adverse events in infants (combined supplemented groups versus non-supplemented group)
| Combined§ (n = 140) |
No Supplement (n = 68) |
p- value* Combined vs. No supplement | |||
|---|---|---|---|---|---|
| # Events | # Infants (%) |
# Events | # Infants (%) |
||
| Adverse events of diarrhea | |||||
| Serious diarrhea | 1** | 1 (0.7%) | 0 | 0 (0.0%) | 1.000 |
| Diarrhea | 21 | 19 (13.6%) | 12 | 11 (16.2%) | 0.675 |
| Total | 22 | 20 | 12 | 11 | – |
| Other serious adverse events of interest | |||||
| All respiratory infections/symptoms | 309 | 119 (85.0%) | 177 | 63 (92.6%) | 0.179 |
| Gastrointestinal infections | 7 | 6 (4.3%) | 7 | 7 (10.3%) | 0.126 |
| Allergies | 11 | 7 (5.0%) | 4 | 3 (4.4%) | 1.000 |
| Deatha | 3 | 3 (2.4%) | 1 | 1 (1,5%) | |
| Other adverse events of interest | |||||
| Vomiting | 0 | 0 (0.0%) | 5 | 4 (5.9%) | 0.011 |
Data are number of infants with at least one event (%).§Combined: supplement and supplement + probiotics groups.*Exact Fisher test p-value.**Event reported in the supplement group. aAs confirmed by clinicians, not related to product consumption