Safety and efficacy of a probiotic-containing infant formula supplemented with 2’-fucosyllactose: a double-blind randomized controlled trial

Table 2 Comparison of weight gain from baseline (≤ 14 days of age) to 4 months of age between formula-fed groups

Population	Groups	Weight gain, g/day LS Mean (SE)	Difference between groups (Experimental-control)^a			P-value for non-inferiority
Population	Groups	Weight gain, g/day LS Mean (SE)	Estimate	95% CI	P-value	P-value for non-inferiority
FAS	Experimental (N = 144)	29.15 (0.65)	0.26	-1.26; 1.79	0.736	< 0.001
FAS	Control (N = 145)	28.89 (0.71)
PP	Experimental (N = 99)	29.13 (0.70)	0.32	-1.33; 1.96	0.704	< 0.001
PP	Control (N = 85)	28.81 (0.79)

(LS mean values and standard errors; 95% confidence interval)
CI Confidence interval, FAS Intention-to-treat, PP per protocol, SE Standard Error
^a From ANCOVA model with formula group, baseline weight, sex, mode of delivery, and study center as covariates

ISSN: 1475-2891