WEEK 8 | |||||||
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Study parameter | A = Active product | C = Control product | A vs C | ||||
n | Mean (week 12–baseline) (SD) | p value* (change from baseline) | n | Mean (week 12–baseline) (SD) | p value* (change from baseline) | p value** | |
IBS-SSS | 50 | −58.30 (84.96) | <0.001 | 40 | −58.33 (73.37) | <0.001 | 0.589 |
Birmingham IBS symptom scale | |||||||
Constipation | 52 | 13.78 (24.47) | <0.001 | 41 | 17.24 (22.61) | <0.001 | 0.302 |
Diarrhoea | 4.25 (13.78) | 0.210 | 2.15 (7.71) | 0.064 | 0.907 | ||
Pain | 11.28 (18.88) | <0.001 | 13.66 (16.80) | <0.001 | 0.257 | ||
Total score | 8.71 (13.09) | <0.001 | 9.44 (9.75) | <0.001 | 0.265 | ||
IBS specific symptoms | |||||||
Pain | 53 | −0.58 (1.24) | 0.012 | 41 | −0.66 (1.43) | 0.002 | 0.292 |
Bloating | 52 | −0.80 (1.44) | 0.005 | −0.85 (1.26) | <0.001 | 0.408 | |
Flatulence | 53 | −0.54 (1.28) | 0.002 | 40 | −0.50 (1.08) | 0.004 | 0.864 |
Composite score | 52 | −1.95 (3.43) | 0.003 | −1.96 (3.17) | <0.001 | 0.374 | |
Stool frequency | 346 | 0.07 (0.95) | 0.303 | 276 | 0.10 (0.05) | 0.141 | 0.828 |
Stool consistency | 290 | 0.18 (1.17) | 0.042 | 218 | 0.50 (1.23) | 0.001 | 0.098 |
Bowel movement difficulty | 291 | −0.43 (1.01) | <0.001 | 224 | −0.40 (0.78) | <0.001 | 0.623 |
IBS Quality of life | |||||||
Dysphoria | 53 | 14.66 (19.87) | <0.001 | 41 | 9.29 (13.95) | <0.001 | 0.508 |
Activity interference | 8.20 (14.74) | 0.001 | 6.05 (12.99) | 0.001 | 0.924 | ||
Body image | 11.95 (15.98) | <0.001 | 8.54 (13.46) | <0.001 | 0.735 | ||
Health worry | 13.29 (17.81) | <0.001 | 7.62 (15.19) | 0.002 | 0.428 | ||
Food avoidance | 10.06 (17.63) | <0.001 | 5.49 (17.84) | 0.039 | 0.372 | ||
Social reaction | 10.85 (16.18) | <0.001 | 6.71 (12.21) | <0.001 | 0.462 | ||
Sexual | 8.41 (18.31) | 0.006 | 7.05 (16.92) | 0.005 | 0.554 | ||
Relationship | 7.23 (18.64) | 0.015 | 7.01 (9.88) | <0.001 | 0.635 | ||
Total score | 10.95 (13.14) | <0.001 | 7.52 (10.22) | <0.001 | 0.483 | ||
WEEK 12 | |||||||
IBS-SSS | 43 | −61.02 (75.78) | <0.001 | 33 | −97.24 (90.17) | <0.001 | 0.028 |
Birmingham IBS symptom scale | |||||||
Constipation | 48 | 6.65 (22.56) | 0.039 | 35 | 17.52 (23.60) | <0.001 | 0.011 |
Diarrhoea | 3.27 (11.17) | 0.048 | 2.43 (10.60) | 0.133 | 0.889 | ||
Pain | 10.28 (14.09) | <0.001 | 15.24 (17.38) | <0.001 | <0.107 | ||
Total score | 6.07 (9.62) | <0.001 | 10.10 (10.78) | <0.001 | <0.022 | ||
IBS specific symptoms | |||||||
Pain | 48 | −0.59 (1.24) | 0.002 | 34 | −1.04 (1.33) | <0.001 | 0.016 |
Bloating | 48 | −0.58 (1.39) | 0.005 | −1.35 (1.21) | <0.001 | 0.006 | |
Flatulence | 48 | −0.64 (1.04) | 0.001 | −0.76 (1.23) | <0.001 | 0.383 | |
Composite score | 48 | −1.81 (3.03) | <0.001 | −3.16 (3.05) | <0.001 | 0.011 | |
Stool frequency | 311 | −0.07 (0.75) | 0.186 | 224 | 0.07 (0.82) | 0.464 | 0.211 |
Stool consistency | 247 | 0.26 (1.22) | 0.045 | 181 | 0.31 (0.99) | 0.012 | 0.784 |
Bowel movement difficulty | 246 | −0.35 (0.99) | <0.001 | 180 | −0.36 (0.86) | <0.001 | 0.329 |
IBS Quality of life | |||||||
Dysphoria | 48 | 13.61 (20.12) | <0.001 | 34 | 10.83 (10.68) | <0.001 | 0.933 |
Activity interference | 8.47 (12.31) | <0.001 | 34 | 7.09 (8.73) | <0.001 | 0.806 | |
Body image | 11.33 (14.16) | <0.001 | 34 | 8.27 (14.08) | 0.005 | 0.857 | |
Health worry | 14.15 (21.01) | <0.001 | 34 | 9.07 (13.19) | <0.001 | 0.634 | |
Food avoidance | 8.16 (20.45) | 0.008 | 34 | 8.58 (13.37) | <0.001 | 0.687 | |
Social reaction | 9.64 (17.15) | <0.001 | 34 | 9.38 (8.74) | <0.001 | 0.660 | |
Sexual | 8.07 (21.34) | 0.031 | 32 | 10.55 (16.53) | <0.001 | 0.382 | |
Relationship | 7.03 (15.81) | 0.002 | 34 | 5.51 (9.22) | <0.001 | 0.751 | |
Total score | 10.43 (12.92) | <0.001 | 34 | 8.83 (6.12) | <0.001 | 0.810 |