A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

BMC Gastroenterology

Table 4 Between and within group comparisons at week 4

Study parameter	Active product			Control product			Active versus control
	n	Mean (week 4–baseline) (SD)	p value* (change from baseline)	n	Mean (week 4–baseline) (SD)	p value* (change from baseline)	p value**
IBS-SSS	41	−53.35 (81.98)	<0.002	44	−31.11 (78.57)	0.010	0.233
Birmingham IBS symptom scale
Constipation	59	9.44 (20.40)	<0.001	49	15.10 (21.59)	<0.001	0.131
Diarrhoea	59	3.88 (12.26)	0.007		2.22 (10.17)	0.106	0.616
Pain	60	7.89 (14.70)	<0.001		11.22 (18.34)	<0.001	0.367
Total score	60	6.10 (10.83)	<0.001		8.28 (11.10)	<0.001	0.251
IBS specific symptoms
Pain	60	−0.33 (1.19)	0.087	49	−0.61 (1.36)	0.001	0.109
Bloating		−0.66 (1.35)	<0.001	48	−0.68 (1.12)	<0.001	0.432
Flatulence		−0.51 (1.24)	<0.001	49	−0.36 (1.07)	0.0017	0.955
Composite score		−1.48 (3.03)	0.002	49	−1.69 (2.99)	<0.001	0.264
Stool frequency	417	0.07 (0.89)	0.202	341	0.04 (0.85)	0.607	0.648
Stool consistency	341	0.13 (1.20)	0.240	269	0.31 (1.30)	0.007	0.184
Bowel movement difficulty	341	−0.24 (0.97)	0.004	271	−0.28 (0.89)	0.011	0.450
IBS Quality of life
Dysphoria	60	9.78 (16.89)	<0.001	50	7.53 (15.54)	0.002	0.875
Activity interference	60	5.68 (10.97)	0.003	50	5.07 (13.77)	0.008	0.769
Body image	60	6.63 (16.28)	<0.001	50	8.13 (17.37)	0.004	0.134
Health worry	60	7.92 (15.20)	0.001	50	5.75 (16.17)	0.009	0.958
Food avoidance	60	9.58 (16.01)	0.002	50	4.42 (18.76)	0.078	0.121
Social reaction	60	7.33 (14.23)	0.003	50	4.17 (14.10)	0.029	0.769
Sexual	59	4.24 (15.68)	0.171	48	4.17 (20.36)	0.125	0.853
Relationship	60	7.15 (15.54)	<0.001	50	1.92 (12.43)	0.217	0.139
Total score	60	7.60 (10.88)	<0.001	50	5.69 (12.60)	0.004	0.979

*ANCOVA with centre as a random effect, baseline as a covariate and product as a fixed effect.
**Ordinal logistic regression with centre and product fixed effects.
Stool frequency, consistency and bowel movement difficulty were recorded daily and therefore n represents the number of data items (days) included in analysis for these items.

ISSN: 1471-230X