FOS (n=54) | Placebo (n=49) | p Value | |
Male, n (%) | 18 (33%) | 22 (45%) | 0.229 |
Mean (SD) age, years | 40 (14.8) | 39 (13.7) | 0.633 |
Mean (SD) duration of CD, years | 11 (7.7) | 10 (7.6) | 0.477 |
Disease site, n (IC/colonic/SB) | 39/10/5 | 33/12/4 | 0.759 |
Resection, n (%) | 24 (44%) | 14 (29%) | 0.111 |
Smoker, n (%) | 18 (33%) | 11 (22%) | 0.220 |
Mean (SD) CDAI at randomisation | 283 (61) | 286 (62) | 0.794 |
Mean (SD) IBDQ at randomisation | 121 (31) | 129 (27) | 0.169 |
Medication | |||
Immunosuppression, n (%) | 24 (44%) | 26 (53%) | 0.382 |
Azathioprine, n (%) | 19 (35%) | 20 (41%) | 0.556 |
Methotrexate, n (%) | 4 (7%) | 6 (12%) | 0.408 |
5-Aminosalicylates, n (%) | 22 (41%) | 25 (51%) | 0.296 |
Prednisolone, n (%) | 3 (6%) | 3 (6%) | 0.902 |
p Values calculated by the Student t test for continuous data and χ2 test or Fisher exact test for categorical data.
CD, Crohn's disease; CDAI, Crohn's Disease Activity Index; IBDQ, Inflammatory Bowel Disease Questionnaire; IC, ileocolonic; SB, small bowel.