Table 1.
Demographic data and prestudy clinical characteristics
| Characteristic | ITT population | PP population | ||
| EcN (n = 162) | Mesalazine (n = 165) | EcN (n = 110) | Mesalazine (n = 112) | |
| Demographic data | ||||
| Males | 56.8% | 52.7% | 55.5% | 50.9% |
| Age (y) (median (range)) | 43 (19–69) | 41 (19–82) | 41 (19–69) | 42 (19–74) |
| Localisation of UC | ||||
| Sub-/total | 26 (16.1%) | 35 (21.3%) | 16 (14.6%) | 24 (21.5%) |
| Left sided | 27 (16.7%) | 35 (21.2%) | 16 (14.5%) | 26 (23.2%) |
| Distal | 102 (63.0%) | 88 (53.4%) | 74 (61.8%) | 57 (44.6%) |
| Duration of UC | ||||
| ⩽5 y | 71 (43.8%) | 84 (50.9%) | 48 (43.6%) | 52 (46.4%) |
| >5 y | 91 (56.2%) | 81 (49.1%) | 62 (56.4%) | 60 (53.6%) |
| Treatment before study (single/combined therapy) | ||||
| Oral salicylates (mg)* | ||||
| ⩽1500 | 60 (37.4%) | 68 (41.2%) | 41 (37.3%) | 46 (41.1%) |
| ⩽3000 | 46 (28.4%) | 47 (28.5%) | 30 (27.3%) | 35 (31.3%) |
| >3000 | 7 (4.3%) | 7 (4.2%) | 7 (4.6%) | 4 (3.6%) |
| Clinical activity index | 0.9 (1.2) | 0.9 (1.2) | 0.8 (1.0) | 0.6 (1.0) |
| Endoscopic index | 1.9 (1.6) | 1.8 (1.5) | 1.5 (1.2) | 1.5 (1.3) |
| Histology (rectum) | ||||
| No signs of active disease | 77.8% | 79.4% | 94.5% | 93.8% |
| Quality of life score | 24 (4.1) | 25.2 (3.7) | 24.5 (3.9) | 24.4 (4.0) |
| Smoker | 10 (6.2%) | 11 (6.7%) | 8 (7.3%) | 9 (8.0%) |
UC, ulcerative colitis; EcN, Escherichia coli Nissle 1917; ITT, intention to treat population; PP, per protocol population.
*Partly combined with steroids.
No significant differences between treatment groups.