Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation

Table 1 Baseline characteristics of the study population

	Total included subjects (n = 456)	Placebo group (n = 226)	Probiotic group (n = 230)
Female	392 (86)	190 (84.1)	202 (87.8)
Age (yr)	40.5 ± 14.26	39.9 ± 14.56	41.2 ± 13.96
Abdominal pain score	3.98 ± 1.05	3.98 ± 1.07	3.97 ± 1.04
Bloating score	4.01 ± 1.17	4.04 ± 1.18	3.99 ± 1.15
Flatulence/borborygmi score	3.64 ± 1.37	3.62 ± 1.46	3.66 ± 1.28
IBS-QOL global score	68.0 ± 17.02	67.2 ± 17.17	68.8 ± 16.86

Values are presented as the mean ± SD or number (%). IBS-QOL: Irritable bowel syndrome-specific quality of life.

Table 2 Descriptive statistics of the proportion of subjects with adverse events

	Placebo group (n = 226)	Probiotic group (n = 230)
Causality with the study product not excluded	13 (5.8)	15 (6.5)
Causality with the research not excluded	1 (0.4)	2 (0.9)
Serious	2 (0.9)	1 (0.4)
Severe	12 (5.3)	17 (7.4)
Moderate	55 (24.3)	74 (32.2)
Mild	39 (17.3)	46 (20.0)

Values are presented as the number of subjects with at least one adverse event, n (%).