Table 1

 Demographic data and prestudy clinical characteristics

CharacteristicITT populationPP population
EcN (n = 162)Mesalazine (n = 165)EcN (n = 110)Mesalazine (n = 112)
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.
Demographic data
    Males56.8%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-/total26 (16.1%)35 (21.3%)16 (14.6%)24 (21.5%)
    Left sided27 (16.7%)35 (21.2%)16 (14.5%)26 (23.2%)
    Distal102 (63.0%)88 (53.4%)74 (61.8%)57 (44.6%)
Duration of UC
    ⩽5 y71 (43.8%)84 (50.9%)48 (43.6%)52 (46.4%)
    >5 y91 (56.2%)81 (49.1%)62 (56.4%)60 (53.6%)
Treatment before study (single/combined therapy)
    Oral salicylates (mg)*
        ⩽150060 (37.4%)68 (41.2%)41 (37.3%)46 (41.1%)
        ⩽300046 (28.4%)47 (28.5%)30 (27.3%)35 (31.3%)
        >30007 (4.3%)7 (4.2%)7 (4.6%)4 (3.6%)
Clinical activity index0.9 (1.2)0.9 (1.2)0.8 (1.0)0.6 (1.0)
Endoscopic index1.9 (1.6)1.8 (1.5)1.5 (1.2)1.5 (1.3)
Histology (rectum)
    No signs of active disease77.8%79.4%94.5%93.8%
Quality of life score24 (4.1)25.2 (3.7)24.5 (3.9)24.4 (4.0)
Smoker10 (6.2%)11 (6.7%)8 (7.3%)9 (8.0%)