. 2025 Feb 24;10(3):e01032-24. doi: 10.1128/msphere.01032-24

TABLE 5.

Tolerability of the investigational product by intervention group

Parameter	Intervention group
Parameter	Placebo	LP1	LP1 + FOS	LP7	LP7 + FOS	P^a
Outcomes by IP attempt, N total attempts	698	730	723	724	715
IP attempts with an immediate intolerability event,^b n (%)	1 (0.1)	5 (0.7)	2 (0.3)	0 (0)	1 (0.1)	0.09
Vomiting within 30 minutes of IP, n (%)	1 (0.1)	4 (0.5)	2 (0.3)	0 (0)	1 (0.1)	0.3
Spitting^c out dose within 1 minute of IP, n (%)	0 (0)	1 (0.1)	0 (0)	0 (0)	0 (0)	0.8
Immediate intolerability event following IP attempts for dose 1,^b^,d,e n (%)	0 (0)	1 (0.9)	1 (1.0)	0 (0)	0 (0)	>0.9
Immediate intolerability event following IP attempts for doses 2–7,^b^,f n (%)	1 (0.2)	4 (0.6)	1 (0.2)	0 (0)	1 (0.2)	0.2
Outcomes by IP visit, N total visits	710	733	725	733	717	NA
Incomplete dose due to caregiver refusal or deferral,^g n (%)	2 (0.3)	2 (0.3)	2 (0.3)	3 (0.4)	0 (0)	0.7
Incomplete dose due to immediate post-ingestion intolerance, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	NA
Outcomes by infant, N total participants^h	101	105	103	104	102	NA
Infants with at least one dose refusal or deferral by caregiver,ⁱ^,j n (%)	2 (2.0)	2 (1.9)	2 (1.9)	3 (2.9)	0 (0)	NA
IP temporarily discontinued,ⁱ n (%)	1 (1.0)	3 (2.9)	1 (1.0)	5 (4.8)	1 (1.0)	0.2
IP permanently discontinued, n (%)	2 (2.0)	3 (2.9)	0 (0)	1 (1.0)	0 (0)	0.3

^{^a}

P-values were derived from permutation testing (see text for details). Statistical testing of comparisons of incomplete IP dose administration across groups was only performed for outcomes where the IP administration visit was the unit of analysis and for events of temporary or permanent IP discontinuation. NA indicates cases where statistical testing of comparisons was not performed.

^{^b}

Directly observed by study personnel within 30 minutes of IP dose.

^{^c}

Study personnel observed for dripping/drooling or spitting out the IP dose, but no events of dripping/drooling were reported.

^{^d}

Dose 1 contained active IP in all groups except placebo.

^{^e}

Among all IP attempts for dose 1, N_Overall = 517; N_Placebo = 101; N_LP1 = 106; N_LP1+FOS = 104; N_LP7 = 104; N_LP7+FOS = 102.

^{^f}

Among all IP attempts for doses 2 to 7, N_Overall = 3073; N_Placebo = 597; N_LP1 = 624; N_LP1+FOS = 619; N_LP7 = 620; N_LP7+FOS = 613.

^{^g}

A deferral was counted if the infant was available for the visit but a caregiver was not available to consent to proceed with IP administration.

^{^h}

Among infants who received at least one dose.

^ⁱ

Despite a break in IP administration, all infants received all seven doses. Infants who eventually had IP permanently discontinued were not included in the “IP temporarily discontinued” category.

^{^j}

Three infants with caregiver dose refusals are also included in the “IP temporarily discontinued” category because the study medical officer agreed that IP should be paused until further review.