TABLE 1.
Baseline demographic and clinical characteristics (ITT population)
| Budesonide (n = 21) | Placebo (n = 23) | |
|---|---|---|
| Female gender, number of patients (n) (%) | 16 (76.2) | 14 (60.9) |
| Age (years), mean (SD) | 52.2 (19.0) | 46.5 (15.5) |
| Body mass index (kg/m2), mean (SD) | 25.7 (5.0) | 27.2 (5.9) |
| Smoking habit, n (%) | ||
| Current | 3 (14.3) | 6 (26.1) |
| Former | 7 (33.3) | 4 (17.4) |
| Never | 11 (52.4) | 13 (56.5) |
| Caffeine intake, n (%) | 18 (85.7) | 16 (69.6) |
| Duration of diarrhoea (years), median (interquartile range) | 1.0 (0.4, 3.9) | 2.1 (0.7, 4.8) |
| Acute onset of symptoms, n (%) | 15 (71.4) | 13 (56.5) |
| Rome III criteria for IBS‐Da fulfilled, n (%) | 13 (61.9) | 20 (87.0) |
| Number of stools/day in the last 7 days, mean (SD) | 4.4 (2.1) | 4.3 (1.4) |
| Number of watery stools/day in the last 7 days, mean (SD) | 2.2 (1.7) | 2.5 (1.7) |
| Number of soft stools/day in the last 7 days, mean (SD) | 1.9 (1.9) | 1.4 (1.0) |
Abbreviations: ITT, intention‐to‐treat; SD, standard deviation.
a
Diarrhoea‐predominant irritable bowel syndrome.