Four-strain probiotic exerts a positive effect on irritable bowel syndrome symptoms occurring in inflammatory bowel diseases in absence of inflammation (train-IBD trial)

Table 1 Demographic and clinical features of the study population, n (%)/mean ± SD

	Total sample (n = 61)	Active treatment (n = 40)	Placebo (n = 21)	P value
Age	42 ± 12	40 ± 11	45 ± 13	0.12
Gender
Female	43 (70.5)	28 (70.0)	15 (71.4)	1.00
Male	18 (29.5)	12 (30.0)	6 (28.6)
Diagnosis
CD	44 (72.1)	31 (77.5)	13 (61.9)	0.24
UC	17 (27.9)	9 (22.5)	8 (38.1)
Disease duration	13 ± 10	10 ± 7	18 ± 12	< 0.01
Previous resection	16 (26.2)	8 (20.0)	8 (38.1)	0.14
Biologic use	40 (65.6)	28 (70.0)	12 (57.1)	0.39
IBS severity
IBS-SSS at baseline	285 ± 115	272 ± 129	308 ± 77	0.25
Mild	9 (14.8)	6 (15)	3 (14)	0.11 (severe vs mild-moderate)
Moderate	26 (42.6)	20 (50.0)	6 (28.6)
Severe	26 (42.6)	14 (35.0)	12 (57.1)

CD: Crohn’s disease; UC: Ulcerative colitis; IBS-SSS: Irritable bowel syndrome-symptom severity score.

Table 2 Inflammatory bowel disease -related outcomes, n (%)

	Total sample (n = 61)	Active agent (n = 40)	Placebo (n = 21)	P value
Biochemical flare	8 (13.1)	4 (10)	4 (19.0)	0.43
Steroid use or escalation of therapy	8 (13.1)	4 (10)	4 (19.0)	0.43
Biochemical flare or steroid or escalation of therapy	10 (16.4)	5 (12.5)	5 (23.8)	0.29