A double-blind, randomized, placebo-controlled trial studying the effects of Saccharomyces boulardii on the gastrointestinal tolerability, safety, and pharmacokinetics of miglustat

Table 2 Primary endpoint: total number of diarrhea days (PP set)

Total number of diarrhea days	Miglustat + S. boulardii	Miglustat + placebo	Paired difference	P-value
Total number of diarrhea days	(n = 34)	(n = 34)	(n = 34)	P-value
Mean (SD)	0.8 (2.4)	1.3 (2.4)	−0.5 (2.4)	0.159*^†
Range (min, max)	0, 13	0, 8	−7, 8	–
95 % CI of mean	0, 1.67	0.46, 2.13	−1.31, 0.37	–
Median	0	0	0	–
Q1, Q3	(0, 0)	(0, 1)	(−1, 0)	–
95 % CI of median	0, 0	0, 1.00	0, 0	–

*Based on paired t test; ^†p = 0.042 based on Wilcoxon paired signed rank test after one outlying subject was excluded during the post-hoc sensitivity analysis

ISSN: 1750-1172