Table 2.

Primary outcome, sensitivity analyses, and secondary outcomes.

	Saccharomyces boulardiiCNCM I-745	Bacillus clausiiO/C, SIN, N/R, T	P value
Primary outcome
Adjusted mean duration diarrhea during study, hrs (95% CI), ITT*	(n = 157) 64.61 (56.45, 72.76)	(n = 158) 77.98 (69.86, 86.11)	.04
Sensitivity analyses
Total mean duration of diarrhea, hrs (95% CI)†	112.2 (103.8, 120.7)	131.4 (123.0, 139.9)	.05
Adjusted mean duration diarrhea during study, hrs (95% CI), APP*	(n = 133) 65.58 (57.65, 73.51)	(n = 130) 80.08 (72.06, 88.09)	.04
Mean ± SD duration of diarrhea by etiology:‡
Bacterial	88.6 ± 64.7 (n = 19)	139.9 ± 47.6 (n = 10)	.04
Viral	54.9 ± 26.6 (n = 20)	59.9 ± 34.6 (n = 21)	.60
Secondary outcomes
Frequency of stools/day on Day 6 (mean ± SD)	1.0 ± 1.2	1.1 ± 1.4	.50
Number (%) with loose stools on Day 6	34 (21.7)	36 (23.1)	.95
Number (%) cured by Day 6	119 (76.3)	113 (71.5)	.38
Time-to first formed stool, mean hours (95% CI)	71.4 (62.0, 82.2)	76.5 (71.4, 94.0)	.11
Recurrence of diarrhea before Day 12, number (%)	3 (1.9)	1 (0.6)	.37
Compliance, % (>80% doses taken)	98.5 ± 6.5	99.3 ± 3.6	.22

APP = as per protocol analysis, CI = confidence interval, hrs = hours, ITT = intent to treat analysis, SD = standard deviation.

^* Adjusted for study site, age (years) and days of diarrhea prior to enrollment.

^† Total duration of diarrhea from initial onset to cessation during study, assessed by parents.

^‡ Bacterial (Salmonella, Shigella, Campylobacter) or viral etiologies (rotavirus, adenovirus).