Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines

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 (%)	p- value* Combined vs. No supplement
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
Death^a	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

ISSN: 1471-2393