Baseline demographic, disease and laboratory characteristics. Disease extent based on Montreal classification for ulcerative colitis.
Characteristic . | Intervention (n = 10) . | Placebo (n = 10) . |
---|---|---|
Women,n(%) | 4 (40%) | 5 (50%) |
Age, mean (SD) | 53.5 (9.3) | 48.0 (12.9) |
Age category, n (%) | ||
18-30 | 0 (0) | 1 (10) |
30-50 | 3 (30) | 5 (50) |
50-70 | 7 (70) | 4 (40) |
Smoking, n (%) | ||
Current | 1 (10) | 1 (10) |
Past | 5 (50) | 3 (30) |
BMI (mean, SD) | 19.6 (7.0) | 26.4 (6.2) |
Time since diagnosis, years (median, IQR) | 16 (2.8-20) | 16 (4.5-23.0) |
Disease extent, n (%) | ||
E1 | 1 (10) | 1 (10) |
E2 | 8 (80) | 3 (30) |
E3 | 1 (10) | 6 (60) |
Disease severity at worst, n (%) | ||
Mild | 1 (10) | 1 (10) |
Mod | 9 (90) | 7 (70) |
Severe | 0 (0) | 2 (20) |
Previous IMM,n(%) | 2 (20) | 3 (30) |
Previous biologic,n(%) | 0 (0) | 0 (0) |
Steroid use in last year,n(%) | 1 (10) | 2 (20) |
Previous steroid use,n(%) | 8 (80) | 6 (60) |
Severity of inflammation at last endoscopy, n (%) | ||
Nil | 2 (20) | 3 (30) |
Mild | 2 (20) | 5 (50) |
Mod | 6 (60) | 2 (20) |
Severe | 0 (0) | 0 (0) |
Baseline SCCAI score (median, IQR) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) |
Baseline SIBDQ (median, IQR) | 59.0 (52.8-64.5) | 59.50 (55.8-64.0) |
Baseline fCal, ug/g (median, IQR) | 32.0 (29.0-38.8) | 33.0 (28.8-64.8) |
Baseline CRP, mg/L (median, IQR) | 1.0 (1.0-8.0) | 1.0 (1.0-1.5) |
Baseline Hb, g/L (median, IQR) | 148.5 (143.3-154.8) | 138.5 (128.5-144.0) |
Baseline ferritin, ug/L (median, IQR) | 109.0 (38.0-157.0) | 83.50 (57.8-99.5) |
Baseline eosinophil count, x109/L (median, IQR) | 0.2 (0.1-0.4) | 0.2 (0.1-0.4) |
Characteristic . | Intervention (n = 10) . | Placebo (n = 10) . |
---|---|---|
Women,n(%) | 4 (40%) | 5 (50%) |
Age, mean (SD) | 53.5 (9.3) | 48.0 (12.9) |
Age category, n (%) | ||
18-30 | 0 (0) | 1 (10) |
30-50 | 3 (30) | 5 (50) |
50-70 | 7 (70) | 4 (40) |
Smoking, n (%) | ||
Current | 1 (10) | 1 (10) |
Past | 5 (50) | 3 (30) |
BMI (mean, SD) | 19.6 (7.0) | 26.4 (6.2) |
Time since diagnosis, years (median, IQR) | 16 (2.8-20) | 16 (4.5-23.0) |
Disease extent, n (%) | ||
E1 | 1 (10) | 1 (10) |
E2 | 8 (80) | 3 (30) |
E3 | 1 (10) | 6 (60) |
Disease severity at worst, n (%) | ||
Mild | 1 (10) | 1 (10) |
Mod | 9 (90) | 7 (70) |
Severe | 0 (0) | 2 (20) |
Previous IMM,n(%) | 2 (20) | 3 (30) |
Previous biologic,n(%) | 0 (0) | 0 (0) |
Steroid use in last year,n(%) | 1 (10) | 2 (20) |
Previous steroid use,n(%) | 8 (80) | 6 (60) |
Severity of inflammation at last endoscopy, n (%) | ||
Nil | 2 (20) | 3 (30) |
Mild | 2 (20) | 5 (50) |
Mod | 6 (60) | 2 (20) |
Severe | 0 (0) | 0 (0) |
Baseline SCCAI score (median, IQR) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) |
Baseline SIBDQ (median, IQR) | 59.0 (52.8-64.5) | 59.50 (55.8-64.0) |
Baseline fCal, ug/g (median, IQR) | 32.0 (29.0-38.8) | 33.0 (28.8-64.8) |
Baseline CRP, mg/L (median, IQR) | 1.0 (1.0-8.0) | 1.0 (1.0-1.5) |
Baseline Hb, g/L (median, IQR) | 148.5 (143.3-154.8) | 138.5 (128.5-144.0) |
Baseline ferritin, ug/L (median, IQR) | 109.0 (38.0-157.0) | 83.50 (57.8-99.5) |
Baseline eosinophil count, x109/L (median, IQR) | 0.2 (0.1-0.4) | 0.2 (0.1-0.4) |
Abbreviations: BMI, body mass index; IMM, immunomodulator; SCCAI, simple clinical colitis activity index; SIBDQ, short inflammatory bowel disease questionnaire; fCal, fecal calprotectin; CRP, C-reactive protein; Hb, haemoglobin
Baseline demographic, disease and laboratory characteristics. Disease extent based on Montreal classification for ulcerative colitis.
Characteristic . | Intervention (n = 10) . | Placebo (n = 10) . |
---|---|---|
Women,n(%) | 4 (40%) | 5 (50%) |
Age, mean (SD) | 53.5 (9.3) | 48.0 (12.9) |
Age category, n (%) | ||
18-30 | 0 (0) | 1 (10) |
30-50 | 3 (30) | 5 (50) |
50-70 | 7 (70) | 4 (40) |
Smoking, n (%) | ||
Current | 1 (10) | 1 (10) |
Past | 5 (50) | 3 (30) |
BMI (mean, SD) | 19.6 (7.0) | 26.4 (6.2) |
Time since diagnosis, years (median, IQR) | 16 (2.8-20) | 16 (4.5-23.0) |
Disease extent, n (%) | ||
E1 | 1 (10) | 1 (10) |
E2 | 8 (80) | 3 (30) |
E3 | 1 (10) | 6 (60) |
Disease severity at worst, n (%) | ||
Mild | 1 (10) | 1 (10) |
Mod | 9 (90) | 7 (70) |
Severe | 0 (0) | 2 (20) |
Previous IMM,n(%) | 2 (20) | 3 (30) |
Previous biologic,n(%) | 0 (0) | 0 (0) |
Steroid use in last year,n(%) | 1 (10) | 2 (20) |
Previous steroid use,n(%) | 8 (80) | 6 (60) |
Severity of inflammation at last endoscopy, n (%) | ||
Nil | 2 (20) | 3 (30) |
Mild | 2 (20) | 5 (50) |
Mod | 6 (60) | 2 (20) |
Severe | 0 (0) | 0 (0) |
Baseline SCCAI score (median, IQR) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) |
Baseline SIBDQ (median, IQR) | 59.0 (52.8-64.5) | 59.50 (55.8-64.0) |
Baseline fCal, ug/g (median, IQR) | 32.0 (29.0-38.8) | 33.0 (28.8-64.8) |
Baseline CRP, mg/L (median, IQR) | 1.0 (1.0-8.0) | 1.0 (1.0-1.5) |
Baseline Hb, g/L (median, IQR) | 148.5 (143.3-154.8) | 138.5 (128.5-144.0) |
Baseline ferritin, ug/L (median, IQR) | 109.0 (38.0-157.0) | 83.50 (57.8-99.5) |
Baseline eosinophil count, x109/L (median, IQR) | 0.2 (0.1-0.4) | 0.2 (0.1-0.4) |
Characteristic . | Intervention (n = 10) . | Placebo (n = 10) . |
---|---|---|
Women,n(%) | 4 (40%) | 5 (50%) |
Age, mean (SD) | 53.5 (9.3) | 48.0 (12.9) |
Age category, n (%) | ||
18-30 | 0 (0) | 1 (10) |
30-50 | 3 (30) | 5 (50) |
50-70 | 7 (70) | 4 (40) |
Smoking, n (%) | ||
Current | 1 (10) | 1 (10) |
Past | 5 (50) | 3 (30) |
BMI (mean, SD) | 19.6 (7.0) | 26.4 (6.2) |
Time since diagnosis, years (median, IQR) | 16 (2.8-20) | 16 (4.5-23.0) |
Disease extent, n (%) | ||
E1 | 1 (10) | 1 (10) |
E2 | 8 (80) | 3 (30) |
E3 | 1 (10) | 6 (60) |
Disease severity at worst, n (%) | ||
Mild | 1 (10) | 1 (10) |
Mod | 9 (90) | 7 (70) |
Severe | 0 (0) | 2 (20) |
Previous IMM,n(%) | 2 (20) | 3 (30) |
Previous biologic,n(%) | 0 (0) | 0 (0) |
Steroid use in last year,n(%) | 1 (10) | 2 (20) |
Previous steroid use,n(%) | 8 (80) | 6 (60) |
Severity of inflammation at last endoscopy, n (%) | ||
Nil | 2 (20) | 3 (30) |
Mild | 2 (20) | 5 (50) |
Mod | 6 (60) | 2 (20) |
Severe | 0 (0) | 0 (0) |
Baseline SCCAI score (median, IQR) | 2.0 (2.0-2.0) | 2.0 (2.0-2.0) |
Baseline SIBDQ (median, IQR) | 59.0 (52.8-64.5) | 59.50 (55.8-64.0) |
Baseline fCal, ug/g (median, IQR) | 32.0 (29.0-38.8) | 33.0 (28.8-64.8) |
Baseline CRP, mg/L (median, IQR) | 1.0 (1.0-8.0) | 1.0 (1.0-1.5) |
Baseline Hb, g/L (median, IQR) | 148.5 (143.3-154.8) | 138.5 (128.5-144.0) |
Baseline ferritin, ug/L (median, IQR) | 109.0 (38.0-157.0) | 83.50 (57.8-99.5) |
Baseline eosinophil count, x109/L (median, IQR) | 0.2 (0.1-0.4) | 0.2 (0.1-0.4) |
Abbreviations: BMI, body mass index; IMM, immunomodulator; SCCAI, simple clinical colitis activity index; SIBDQ, short inflammatory bowel disease questionnaire; fCal, fecal calprotectin; CRP, C-reactive protein; Hb, haemoglobin
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